Systems, devices, and methods for minimally invasive pelvic surgery

ABSTRACT

The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence. 
     The invention also provides a driver and methods for advancing needles, cannulas, and other medical devices through the pubic bone. The driver may be used in connection with a driver frame assembly for proper positioning and stabilization of the driver, and with other devices for creating a cavity in the urethral floor and for positioning medical devices therein. The invention also provides simple connections for attaching a suture to a device within the cavity in the urethral floor or in the vagina, and also for attaching sutures to the pubic bone.

RELATED APPLICATIONS

This application is a continuation of prior application Ser. No.11/495,971, filed Jul. 28, 2006, now U.S. Pat. No. 7,614,999, which is acontinuation of prior application Ser. No. 10/939,191, filed Sep. 10,2004, now U.S. Pat. No. 7,691,052, which is a continuation of priorapplication Ser. No. 10/774,826, filed Feb. 9, 2004, now U.S. Pat. No.7,691,050, and prior application Ser. No. 10/774,842, filed Feb. 9,2004, now U.S. Pat. No. 7,413,540, both of which are continuations ofapplication Ser. No. 10/015,114, filed Nov. 12, 2001, now U.S. Pat. No.6,752,814, which is a continuation of application Ser. No. 09/023,965,filed Feb. 13, 1998, now U.S. Pat. No. 6,423,080, which claims thebenefit of and priority to U.S. Provisional Patent Application Ser. No.60/038,171, filed Feb. 13, 1997, all of which are hereby incorporated byreference in their entirety.

FIELD OF THE INVENTION

Part A

The present invention relates to devices and methods for treatingincontinence.

Part B

The present invention relates to methods and devices for improvingurinary incontinence. More particularly, the present invention relatesto methods and devices for creating a cavity near the urethral floor,methods and devices for placement of a urethral sling or other device insuch a cavity, and methods and devices for driving bone-piercing guidesinto and through the pubic bone for use in stabilizing the urethral orpelvic floor.

BACKGROUND OF THE INVENTION

Part A

Urinary incontinence is a widespread problem in the United States andthroughout the world. Urinary incontinence affects people of all agesand can severely impact a patient both physiologically andpsychologically.

In approximately 30% of the women suffering from urinary incontinence,incontinence is caused by intrinsic sphincter deficiency (ISD), acondition in which the valves of the urethral sphincter do not properlycoapt. In approximately another 30% of incontinent women, incontinenceis caused by hypermobility, a condition in which the muscles around thebladder relax, causing the bladder neck and proximal urethra to rotateand descend in response to increases in intraabdominal pressure.

Hypermobility may be the result of pregnancy or other conditions whichweaken the muscles. In an additional group of women with urinaryincontinence, the condition is caused by a combination of ISD andhypermobility.

In addition to the conditions described above, urinary incontinence hasa number of other causes, including birth defects, disease, injury,aging, and urinary tract infection.

Numerous approaches for treating urinary incontinence are available. Forexample, several procedures for stabilizing and/or slightly compressingthe urethra so as to prevent the leakage of urine have been developed.The stabilizing or compressive force may be applied directly by suturespassing through the soft tissue surrounding the urethra or,alternatively, may be applied by means of a sling located under theurethra and suspended by sutures. The sutures may be anchored to thepubic bone by means of bone anchors or, alternatively, the sutures maybe attached to other structures such as fascia.

A device for dissecting around a tubular structure such as the urethraor the bladder neck is available from Lone Star Medical Products. TheLone Star device has two shafts which can be positioned in the tissuebetween the urethra and the vaginal wall using cystoscopy, vaginal orrectal examination, or an examination of the position of the instrumentaround the urethra with the bladder opened. The two shafts can be lockedtogether to pinch the intervening tissue. A sharp blade is inserted intoone of the shafts and advanced into the second shaft, cutting the tissuein between the two shafts. The cut in the tissue can be expanded using aright angle clamp and an artificial sphincter guided by a sutureattached to the cutting blade of the device can be introduced into theexpanded cut.

With the Lone Star device, the distance between the two shafts cannot begradually adjusted. In addition, the ends of the shafts of the Lone Stardevice come in direct contact with the tissue or bone while beingadvanced towards the tissue between the urethra and the upper vaginalwall. The shafts of the Lone Star device are flat at their distal ends.

Thus, there is a need for devices which simplify treatments for urinaryincontinence and increase their safety. Sling application devices fortreating urinary incontinence which reduce the risk of inadvertentpinching of the urethra and undesirable scoring of tissue or bone duringadvancement of the device would be particularly desirable. It is alsodesirable to have a sling application device that does not employ aguiding suture and can create or maintain an opening in the tissuebetween the urethra and the upper vaginal wall without the use of aright angle clamp, thereby simplifying the procedure.

U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al.,introduces pioneering minimally invasive percutaneous and transvaginalbladder neck stabilization approaches. The percutaneous approach ofBenderev et al. involves stabilizing the bladder neck using a boneanchor which is percutaneously introduced from the abdominal side of thepatient. The transvaginal approach of Benderev et al. involvesstabilizing the bladder neck using a staple or bone anchor which istransvaginally placed into the pubic bone. There is also a need forfurther devices and methods for improving or maintaining urinarycontinence involving stabilization or compression of the bladder neck orurethra, particularly devices and methods of the present invention thatare less invasive than many of those currently available.

Part B

The present invention relates to the treatment of stress urinaryincontinence “SUI,” and to improved methods and surgical devices for thesurgical treatment of SUI. The devices disclosed herein are additionallyuseful in a wide variety of other surgical procedures.

Genuine stress incontinence is the involuntary loss of urine due to asudden rise in intra-abdominal pressure. It has been estimated thatbetween 40% and 50% of young, healthy nulliparous women admit tooccasional mild stress incontinence; however, at least 80% of stressincontinence patients are in the perimenopausal age group and aremultiparous. Raz has suggested that the female urethral continencemechanism is dependent on the interaction of four urethral factors:urethral closing pressure, urethral length, urethrotrigonal anatomy, andurethral reception of intraabdominal pressure. Raz, S., Modified bladderneck suspension for female stress incontinence, Urology, 17:82, 1981.

The urethral closing pressure is predominantly a result of theinteraction of smooth and striated muscle sphincter activity, but thereis also some contribution by nonmuscular urethral factors such as thesubmucosal vascular plexus, the elastin and collagen content of theurethral tissues, and a sphincter like effect of the mucosa. There hasbeen considerable diversity of opinion regarding the anatomic structureand the innervation of the urethral sphincters, and a variety of viewshave been expressed in the literature.

Urethral length is important in the maintenance of continence. However,although it certainly interacts with other factors to contribute tocontinence, a short urethra alone will not produce incontinence.Urethral length varies considerably in normal women, and women withproven genuine stress urinary incontinence do not invariably haveurethral shortening.

Urethrotrigonal anatomy, which can be demonstrated by lateralcystourethrography, should fulfill certain criteria. The bladder baseshould lie above the level of the inferior ramus of the symphysis, andwith straining should not descend more than 1.5 cm. There should be anormal urethrotrigonal alignment with an angle normally less than 100degrees, and the urethral axis should be approximately 35 degrees fromthe vertical. In the hypermobile situation loss of all of the normalanatomic features may occur, a radiologic finding that correlates withthe clinical finding of cystourethrocele. However, clinical experiencehas shown that the coexistence of cystourethrocele and incontinence doesnot predict that the incontinence is of a genuine stress variety.

The transmission of intra-abdominal pressure to the intra-abdominalportion of the proximal urethra is also reported to be important in themaintenance of continence. This is a passive phenomenon, and is theresult of the normal anatomic configuration just described. Wheneverthere is a rise in intra-abdominal pressure during such stresses ascoughing or straining, the pressure is transmitted not only to thebladder but also to the proximal urethra, with resultant increase in theclosing pressure, and prevention of leakage. If the urethral axis isaltered, rotational descent will drop the proximal urethra and bladderbase from its intra-abdominal location, and will obviously impair suchpressure transmission.

A wide variety of operations have been used to correct this condition,generally involving the principles of elevating the bladder neckanteriorly and/or elongating and narrowing the proximal urethra. Two ofthe most popular operations today for stress incontinence are theMarshall-Marchetti-Krantz and Birch vesicourethropexies. TheMarshall-Marchetti-Krantz technique has at least an eighty-five percentsuccess rate, against which other operative success rates must bemeasured. Recently, the Pereyra operation and its modifications haveenjoyed some popularity, but less than basic techniques.

Notwithstanding the foregoing, however, there remains a need for animproved treatment for SUI. Preferably, the treatment is as noninvasiveas possible under the circumstances, and will eliminate or minimizehospitalization and the use of general anesthetics. In addition, thereremains a need for improved medical instrumentation such as tissuecavity dilators, incision guides, bone-piercing guide drivers, andquick-connect slings and suture-securing devices for use in connectionwith SUI treatment and other medical procedures. U.S. patent applicationSer. No. 08/042,739, entitled “Bladder Neck Suspension Procedure”, filedApr. 5, 1993 by Benderev et al., now issued U.S. Pat. No. 5,611,515,introduces pioneering minimally invasive percutaneous and transvaginalbladder neck stabilization approaches. The percutaneous approach ofBenderev et al. involves stabilizing the bladder neck using a boneanchor which is percutaneously introduced from the abdominal side of thepatient. The transvaginal approach of Benderev et al. involvesstabilizing the bladder neck using a staple or bone anchor which istransvaginally placed into the pubic bone. The methods and devices ofthe present invention may be used in several urethral or bladder neckstabilization procedures that are less invasive than many of thosecurrently available.

SUMMARY OF THE INVENTION

Part A

The present invention relates to devices and methods for use inpercutaneous and hiatal approaches treatments for urinary incontinence.In particular, the present invention relates to guide member placementdevices, sling application catheters, tissue dissectors/dilators, slingapplication devices and a sling application system, tissue expanders,grasping devices, and balloon catheters. Methods for using the precedingdevices to stabilize the bladder neck or the urethral floor in order tomaintain or improve urinary continence are also disclosed.

One aspect of the present invention is a guide member placement devicefor inserting a guide member in a body tissue. The guide memberplacement device comprises a shaft having a proximal end, a distal end,and a lumen extending therethrough. The lumen of the shaft is adaptedfor receiving a guide member. The distal end of the shaft has anengaging member for engaging another guide member placement device. Inone embodiment of the guide member placement device, the device furthercomprises a blunt dissection tip at the distal end of the shaft and ahandle with a lumen extending therethrough wherein the lumen of theshaft and the lumen of the handle are aligned. In a further embodiment,the blunt dissection tip is on a blunt dissector within the shaft and isextendable from and retractable in the shaft. In a further embodiment,the guide member placement device is adapted for use in urethral floorreconstruction procedures. In yet another embodiment, the guide memberplacement device is adapted for use in bladder neck stabilizationprocedures. In one embodiment of the guide member placement device, theengaging member comprises a male connector. In another embodiment of theguide member placement device, the engaging member comprises a femaleconnector. In yet another embodiment of the guide member placementdevice, the shaft has a straight proximal section, a bent intermediatesection and a distal end oriented at an angle of approximately 90degrees relative to the proximal section. In another embodiment, theguide member placement device further comprises a guide member removablypositioned in the lumen of the shaft. In one aspect of this embodiment,the guide member comprises a guide wire. In another aspect of thisembodiment, the guide member comprises a suture.

Another aspect of the present invention is a method of inserting a guidemember into a body tissue. A shaft of a first guide member placementdevice is inserted percutaneously and advanced through the body tissueto a central point through which the guide member will pass. A shaft ofa second guide member placement device is inserted percutaneously andadvanced through the body tissue to the central point through which theguide member will pass. An engaging member on a distal end of the shaftof the first guide member placement device is coupled to an engagingmember on a distal end of a shaft of a second guide member placementdevice such that a lumen in the shaft of the first guide memberplacement device is fluid communication with a lumen in the shaft of thesecond guide member placement device. A guide member is passed throughthe lumens of the coupled shafts of the first guide member placementdevice and the second guide member placement device. The shaft of thefirst guide member placement device and the shaft of the second guidemember placement device are removed from the body, thereby leaving theguide member in the body tissue. In one embodiment of the method, thefirst and second shafts are percutaneously inserted through first andsecond suprapubic incisions. In another embodiment of the method, theshafts of the first and second guide member placement devices areinserted into a pre-formed opening or pocket in the body tissue. Inanother embodiment of the method, the method further comprises the stepof creating an opening in the body tissue by extending and retracting ablunt dissector tip from at least one of the guide member placementdevices. In another embodiment of the method, the pre-formed opening orpocket is in the tissue between the urethra and the upper vaginal wallsuch that the guide member is left in the pre-formed opening or pocket.

Another aspect of the present invention is a sling application cathetercomprising a catheter having a sling therein, wherein the sling isreleasably engaged with the catheter. In one embodiment of the slingapplication catheter, the catheter has a pouch therein for releasablyengaging the sling. The sling application catheter of claim 18, whereinsaid catheter is adapted to travel over a guide member. In yet anotherembodiment of the sling application catheter, the distal end of thecatheter is tapered. In yet another embodiment of the sling applicationcatheter, the distal end of the pouch is tapered. In one embodiment ofthe sling application catheter, the pouch is porous. In anotherembodiment of the sling application catheter, the pouch furthercomprises a stiffener for increasing its rigidity. The stiffener may bein the interior of the pouch or on the exterior of the pouch. In anotherembodiment of the sling application catheter, the stiffener is porous.

Another aspect of the present invention is a method of introducing asling into a body tissue. The method comprises the steps of passing asling application catheter catheter through the body tissue. The slingapplication catheter comprises a catheter having a sling therein whichis releasably engaged to the catheter. The sling is released form thesling application catheter, thereby introducing the sling into the bodytissue.

In one aspect of the method of introducing a sling into a body tissue,the method further comprises making a first incision and a secondincision and the step of passing the sling application catheter throughthe body tissue comprises passing the sling application catheter intothe first incision and out of the second incision. In one embodiment ofthe method of introducing a sling into a body tissue, the sling isreleased from the sling application catheter by withdrawing the slingfrom a pouch in the sling application catheter. In another embodiment,the sling application catheter is passed through the body tissue over aguide member. In yet another embodiment, the sling is introduced intothe tissue between the urethra and the upper vaginal wall. In stillanother embodiment, the first incision and the second incision aresuprapubic incisions. In another embodiment, the method furthercomprises the step of withdrawing the sling from the pouch by graspingan end of the sling while withdrawing the distal end of the slingapplication catheter out of the second suprapubic incision. In yetanother embodiment, the step of withdrawing the sling from the pouchcomprises withdrawing a sterile sling.

Another aspect of the present invention is a tissue dissector/dilatorfor creating and dilating an opening or pocket in a body tissue. Thetissue dissector/dilator comprises a body, a noncompliant shaft attachedto the body, a dissector carried on the shaft for creating an opening orpocket in the body tissue, and a dilator carried on the shaft fordilating the opening or pocket in the body tissue. In one embodiment,the shaft has a lumen extending therethrough and the dissector is withinthe lumen in the shaft and is axially movable, such that the dissectorcan be extended from and retracted in the shaft. In another embodiment,the shaft has a lumen extending therethrough and the dilator is withinthe lumen in the shaft and is axially movable, such that the dilator canbe extended from and retracted in said shaft. In another embodiment, theshaft has a lumen extending therethrough and both the dissector and thedilator are within the lumen of the shaft and are axially movable, suchthat the dissector and the dilator can be extended from and retracted inthe shaft. In one embodiment, the axially movable dissector and theaxially movable expandable dilator are integral. In another embodiment,the tissue dissector/dilator is adapted for use in bladder neckstabilization procedures.

In still another embodiment of the tissue dissector/dilator, the body ofthe tissue dissector/dilator further comprises a first control memberfor extending and retracting the axially movable integral dissector andexpandable dilator between a first position in which the dissectorextends from the shaft, a second position in which both the dissectorand the dilator extend from the shaft, and a third position in which thedissector and the dilator are retracted inside the shaft. In thisembodiment, the body of the tissue dissector/dilator also comprises asecond control member for expanding the dilator in the opening or pocketin the body tissue, thereby dilating the opening or pocket and forcollapsing the dilator following dilation of the opening or pocket. Inanother embodiment, the first control member for extending andretracting the axially movable integral dissector and expandable dilatorcomprises a spring return button which engages the axially movableintegral dissector and expandable dilator so as to extend or retractsaid axially movable integral dissector and expandable dilator. In stillanother embodiment, the spring return button can be positioned to lockthe axially movable integral dissector and expandable dilator in a fullyextended position. In yet another embodiment, the spring return buttonprovides a one to one stroke motion to the axially movable integraldissector and expandable dilator.

In a further embodiment of the tissue dissector/dilator, the axiallymovable integral dissector and expandable dilator is a cathetercomprising an outer tube having a lumen extending therethrough and atleast one expandable balloon in the lumen of the outer tube. In thisembodiment, the expandable balloon has an inflation tube at its proximalend and a blunt dissector at its distal end, wherein the inflation tubeis in fluid communication with the interior of the balloon. In stillanother embodiment, the second control member for expanding the dilatorcomprises a trigger on the body and a syringe in the body comprising aplunger, a reservoir, and a tip. In this embodiment, the tissuedissector/dilator also comprises a syringe locking mechanism, whereinthe tip of the syringe fixedly engages the syringe locking mechanism toplace the reservoir of the syringe in fluid communication with theballoon catheter, and the trigger engages the plunger of the syringesuch that squeezing the trigger depresses the plunger of the syringethereby dispensing fluid from the syringe and expanding the balloon ofthe catheter. In still another embodiment, the catheter furthercomprises a second lumen adapted for passage of a guide member. In afurther embodiment, the catheter further comprises a third lumen. Inanother embodiment, the third lumen is adapted for receiving anultrasound catheter. In still another embodiment, the third lumen isadapted for receiving an implant. In another embodiment, the third lumenis adapted for irrigation.

Another aspect of the present invention is a tissue dissector/dilatorfor creating and dilating an opening or pocket in a body tissuecomprising a body, a noncompliant shaft attached to said body, adissection means carried on the shaft for dissecting an opening orpocket in a body tissue, and a dilation means carried on the shaft fordilating the opening or pocket,

Another aspect of the present invention is a method of creating anddilating an opening or pocket in a body tissue. A noncompliant shaft ofa tissue dissector/dilator is percutaneously inserted into the bodytissue. The shaft is advanced through the body tissue. A dissector isextended from a distal end of the shaft to create a first opening orpocket in the body tissue and a dilator is extended from the distal endof the shaft. The dilator is expanded within the first opening or pocketto dilate the first opening or pocket. In one embodiment of the method,the tissue dissector/dilator is percutaneously inserted through asuprapubic incision. In another embodiment, the body tissue is thetissue between the urethra and the upper vaginal wall and the firstopening or pocket is perpendicular to the longitudinal axis of theurethra and extends from one side of the urethra to the other. Inanother embodiment the method further comprises percutaneously insertinga noncompliant shaft of a second tissue dissector/dilator into the bodytissue, advancing the noncompliant shaft of the second tissuedissector/dilator through the body tissue, extending a dissector from adistal end of the shaft of the second tissue dissector/dilator to createa second opening or pocket in the tissue, extending a dilator from thedistal end of the shaft of the second tissue dissector/dilator andexpanding said dilator within the second opening or pocket, therebydilating the second opening or pocket and forming from the first andsecond openings or pockets a continuous opening or pocket in the bodytissue. In a further embodiment, the second tissue dissector/dilator ispercutaneously inserted through a suprapubic incision. In yet anotherembodiment of the method, the body tissue is the tissue between theurethra and the upper vaginal wall and the continuous opening or pocketis perpendicular to the longitudinal axis of the urethra and extendsfrom one side of the urethra to the other.

Another aspect of the present invention is a sling application devicefor inserting a sling into a pocket in a body tissue. The slingapplication device comprises a first shaft and a second shaft. The firstand second shafts have lumens extending therethrough. The lumens havedimensions adapted for receiving a sling therein. The sling applicationdevice also comprises an adjuster for incrementally adjusting thedistance between said first and second shafts. In one embodiment, thelumens of the first and second shafts have dimensions adapted forreceiving a sling introducer having a sling releasably engaged thereto.In another embodiment, the sling application device further comprises afirst handle attached to the first shaft and a second handle attached tothe second shaft. In this embodiment, the first and second handles haveopenings therein which are in fluid communication with the lumens in theshafts to which the handles are attached and the first and secondhandles are adapted to be connected to one another. In anotherembodiment, the adjuster engages the first and second handles.

In one embodiment of the sling application device the first and secondshafts are curved. In still another embodiment, the first and secondshafts have a small radius 90° curve at their distal ends, such that thefirst and second shafts are adapted for use in urethral stabilizationprocedures. In another embodiment, the first and second shafts have aside bend. In yet another embodiment, the radius of curvature at thedistal ends of the first and second shafts is not planar with the axialportions of the shafts of the first and second shafts. In still anotherembodiment, the upper edges of the distal ends of the first and secondshafts are indented relative to the lower edges. In another embodiment,the first and second handles are adapted for interlocking. In a furtherembodiment, the adjuster comprises an articulating lock. In stillanother embodiment, the first shaft and the second shaft arecylindrical. In one embodiment, the first shaft and the second shaftcomprise flat tubes. In another embodiment, the portion of the firstshaft and the second shaft proximal to the bend is cylindrical and theportion distal to the bend is a flat tube. In another embodiment, theproximal portions of the first and second shafts are oriented at anangle of about 90° relative to the distal portions of the first andsecond shafts. In another embodiment, the sling application devicefurther comprises a blunt dissector for dissecting the body tissuewithout scoring or creasing tissue or bone with which it comes incontact. In this embodiment, the blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end. The rigid tip protrudes from the distal ends of thefirst and second shafts of the sling application device when the bluntdissector is inserted into the first and second shafts of the slingapplication device. In yet another embodiment, the blunt dissectorcomprises an obturator.

Another aspect of the present invention is a sling introducer adaptedfor introducing a sling attached thereto into an opening or pocket in abody tissue without the use of sutures. The sling introducer comprises asling engager having the sling releasably engaged thereto. The slingengager is adapted for advancement through a first shaft and a secondshaft of a sling application device. The length of the sling introduceris at least equal to the sum of the lengths of the first and secondshafts of the sling application device. In one embodiment, the slingengager comprises a pouch for releasably engaging said sling. In anotherembodiment, the pouch has pores therein for permitting a solution toaccess said sling. In still another embodiment, the distal end of thepouch has a narrow lead. In a further embodiment, the pouch isreinforced.

Another aspect of the present invention is a tissue cutter for forming acavity in a tissue. The tissue cutter comprises an elongated housingadapted to fit within a shaft of a sling application device and anextendable and a retractable blade within the housing. The blade isadapted to form the cavity in the tissue. In one embodiment, the bladecomprises a razor. In another embodiment, the razor is sized such thatthe cavity formed with the razor has dimensions adapted for insertion ofa sling therein.

Another aspect of the present invention is a sling application system.The sling application system includes a sling application devicecomprising a first shaft and a second shaft. The first and second shaftsof the sling application device have lumens extending therethrough. Thelumens have dimensions adapted for receiving a sling introducer therein.The sling application device also comprises an adjuster forincrementally adjusting the distance between the first and secondshafts. The sling application system also includes a blunt dissector fordissecting a body tissue without scoring or creasing tissue or bone withwhich it comes in contact. The blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end wherein the generally rigid tip protrudes from thedistal ends of the first and second shafts of the sling applicationdevice when the blunt dissector is inserted into the first and secondshafts. The sling application system also comprises a sling introducerfor introducing a sling attached thereto into an opening or pocket inthe body tissue without the use of sutures. The sling introducercomprises a sling engager having the sling releasably engaged thereto.The sling engager is adapted for advancement through the lumens of thefirst and second shafts of the sling application device wherein thesling introducer has a length sufficient to extend between the first andsecond shafts of the sling application device. In one embodiment, thesling application system further comprises a tissue cutter for forming acavity in the body tissue. The tissue cutter comprises an elongatedhousing adapted to fit within the second shaft of the sling applicationdevice and an extendable and retractable blade within the housing. Theblade is adapted to form a cavity in the body tissue.

Yet another aspect of the present invention is a method for introducinga sling into a body tissue. A first blunt dissector is inserted into afirst shaft of a sling application device. The first shaft having thefirst blunt dissector therein is inserted percutaneously and advancedthrough the body tissue. A second blunt dissector is inserted into asecond shaft of the sling application device. The second shaft havingthe second blunt dissector therein is inserted percutaneously andadvanced through the body tissue. The distance between the distal endsof said first and second shafts is decreased. A sling introducer havingthe sling releasably engaged thereto is advanced between the first andsecond shafts of the sling application device. The sling is releasedfrom the sling introducer. The first and second shafts are removed fromthe body tissue, thereby introducing the sling into the body tissue. Inone embodiment, the method further comprises making a first incision anda second incision wherein the first shaft of the sling applicationdevice is inserted into the first incision prior to advancing it throughthe body tissue and the second shaft of the sling application device isinserted into the second incision prior to advancing it through the bodytissue. In another embodiment, the sling is introduced into a pre-formedpocket in the tissue between the urethra and the vaginal wall. In afurther embodiment, the first incision and the second incision aresuprapubic incisions. In still another embodiment, the method furthercomprises inserting a tissue cutter into the first shaft of the slingapplication device and extending the tissue cutter into the body tissuebetween the distal ends of the first and second shafts, therebydissecting the body tissue.

Another aspect of the present invention is a balloon catheter comprisingan outer tube having a lumen extending therethrough and at least oneexpandable balloon adapted for dilating an opening or pocket in thetissue between the urethra and the upper vaginal wall. The expandableballoon has a proximal end and a distal end in the lumen of the outertube. The expandable balloon also has an inflation tube at its proximalend. The inflation tube is in fluid communication with the interior ofthe balloon. In one embodiment, the expandable balloon has a bluntdissection tip at its distal end which has sufficient rigidity to allowit to create an opening or pocket in the solid body tissue. In oneembodiment, the balloon catheter comprises a plurality of expandableballoons in fluid communication with the inflation tube. In anotherembodiment, the balloon catheter is adapted to fit in the lumen of alarge bore needle. In still another embodiment, the expandable balloonhas a flat profile. In another embodiment, the balloon further comprisesinternal non-expansive ribs. In yet another embodiment, the catheterextends into the interior of the balloon. In still another embodiment,the balloon is on the exterior surface of the catheter.

Another aspect of the present invention is a detachable member slingapplication device for introducing a sling having sutures attachedthereto into an opening or pocket in a body tissue. The detachablemember sling application device has a housing with an introduction shaftconnected thereto. The introduction shaft has a lumen extendingtherethrough which is adapted to receive the sling having suturesattached thereto. The detachable member sling application device alsohas a detachable member on the distal end of the introduction shaft. Thedetachable member is connected to at least one of the sutures attachedto the sling. In one embodiment, the detachable member sling applicationdevice further comprises an axially movable needle. In this embodiment,the needle comprises a needle shaft and a sharpened point. The needle islocated inside the lumen of the introduction shaft and is extendabletherefrom.

Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue,comprising a shaft having an engaging member at its distal end. Theengaging member is adapted to engage a detachable member connected to asuture attached to the sling.

Another aspect of the present invention is a method of stabilizing thebladder neck. A pocket or opening is formed in the tissue between theurethra and the upper vaginal wall. A sling application device isinserted into the pocket or opening. A sling is introduced into thepocket or opening with the sling application device. The sling issecured to tissue or bone to stabilize the bladder neck. In oneembodiment the method further comprises providing a detachable membersling application device. The detachable member sling application devicehas a housing with an introduction shaft connected thereto. Theintroduction shaft has a lumen extending therethrough which is adaptedto receive the sling having sutures attached thereto. The detachablemember sling application device also has a detachable member on thedistal end of the introduction shaft. The detachable member is connectedto at least one of the sutures attached to the sling. In thisembodiment, the step of inserting a sling application device into thepocket or opening comprises inserting the detachable member slingapplication device into the opening or pocket. Another step in thisembodiment comprises detaching a detachable member from a distal end ofthe shaft of the detachable member sling application device. Thedetachable member is connected to the sling. Another step in thisembodiment comprises introducing a shaft of a retrieval device into theopening or pocket. Yet another step in this embodiment comprisesengaging the detachable member with an engaging member on the shaft ofthe retrieval device. Another step of this embodiment compriseswithdrawing the shaft of the retrieval device from the opening orpocket, thereby introducing the sling of the detachable member slingapplication device into the opening or pocket. In another embodiment,the method further comprises extending an axially movable needle from adistal end of the shaft of the detachable member sling applicationdevice into the body tissue and toggling the needle to move thedetachable member within the opening or pocket. In still anotherembodiment, the opening or pocket is in a hiatus between a urethra andan upper vaginal wall. In another embodiment, the method furthercomprises the step of expanding the opening or pocket in the hiatususing a balloon catheter having at least one expandable balloon with ablunt dissection tip at its distal end. In this embodiment, the bluntdissection tip has sufficient rigidity to allow it to make the openingin the body tissue when contacting the tissue.

Another aspect of the present invention is a device for expanding anopening or pocket within a body tissue. The device comprises a tubehaving a lumen extending therethrough, an axially movable expandable andcollapsible expansion basket attached to the tube for insertion into theopening or pocket within the body tissue and expansion thereof, and anexpansion and collapse control in communication with the expandable andcollapsible basket for expanding and collapsing the basket. In oneembodiment, the basket comprises a plurality of wires. In anotherembodiment, the expansion and collapse control comprises a pull wire.

Another aspect of the present invention is a grasping device adapted forinsertion into a lumen of an expansion device having an expansion basketfor expanding an opening or pocket within a body tissue. The graspingdevice comprises a catheter having a grasping member on its distal endfor grasping a suture or guide member which has been advanced into theexpansion basket of the expansion device. In one embodiment, thegrasping member comprises a self-expanding basket. In anotherembodiment, the self-expanding basket is adapted to fit inside theexpansion basket of the expansion device when the expansion basket ofthe expansion device is in an expanded configuration.

Another aspect of the present invention is a method of creating a pocketin the tissue between the urethra and the upper vaginal wall comprisinghydrodissecting the tissue.

Another aspect of the present invention is a method for holding a pocketin a body tissue in an open position. A lumen is made in the bodytissue. The lumen in the body tissue is expanded to create the pocket inthe body tissue. An expansion device is inserted into the pocket and anexpansion basket on the expansion device is expanded in the pocket,thereby holding the pocket in the open position. In one embodiment, thebody tissue comprises a hiatus between a urethra and an upper vaginalwall. In another embodiment, the lumen is expanded with a ballooncatheter. In another embodiment, the method further comprises insertinga suture or guide member through a suprapubic incision into the pocket,inserting a grasping device comprising a catheter having a graspingmember on its distal end into a lumen of the expansion device, graspingthe suture or guide member with the grasping device, and withdrawing thesuture or guide member to a desired position. In one embodiment, thesuture or guide member is grasped under direct vision.

Yet another aspect of the invention is a method of introducing a slinginto an opening in a body tissue comprising holding a pocket or openingin a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guide wire within the expandedopening as described above, and drawing the suture or guide wire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. The two suturesare tied together and used to guide a sling into the opening. In oneembodiment, the body tissue comprises a hiatus between the urethra andthe upper vaginal wail.

Yet another aspect of the invention is a method of introducing a slinginto an opening in a body tissue comprising holding a pocket or openingin a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guide wire within the expandedopening as described above, and drawing the suture or guide wire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. A sling isattached to the two sutures outside of the patient's body and introducedinto the opening in the body tissue. In one embodiment, the body tissuecomprises a hiatus between the urethra and the upper vaginal wall.

Part B

It is an objective of this invention to provide a means and method forrelatively sterile placement of urethral slings. It is a furtherobjective of this invention to provide an apparatus for straight linepositioning for bone piercing, so as to achieve proper placement ofurethral slings and to minimize difficulty in aligning a bone-piercingapparatus with the ultimate target in a tissue cavity. Another objectiveis to provide apparatus and a method for reconstructing and stabilizingthe urethral or pelvic floor by affixing devices placed to support theurethral or pelvic floor to a fixed reference tissue such as a bone. Afurther objective is to provide improvements over current techniquesthat require drilling holes in a bone, and the placement of bone anchorstherein.

This invention has the additional objective of providing rapid andsimple surgical connections for connecting a suture to a medical deviceinside a tissue cavity or other structure in the body that may be inneed of stabilization. This invention also seeks to provide alternativesto transvaginal methods of urethral and pelvic floor reconstruction andstabilization, to minimize the risk of infection, and to enable surgeonsto approach the urethral or pelvic floor from different locations.Finally, it is a further objective to provide minimally invasive meansand methods of securing a target tissue to an immoveable referencetissue, such as the pubic bone. One of more of these objectives issatisfied by various embodiments of the invention.

The invention provides a dilator for creating a cavity in tissue. Thedilator has two functional portions: an insertion spreader and handles.The insertion spreader includes of two facing guides that may besemi-cylindrical. The spreader has open and closed positions. In theclosed position the guides are close together and the dilator may havethe appearance of a split tube or cylinder, while in the open positionthe guides are separated. In both positions the guides remainessentially parallel to each other.

The insertion spreader may be attached to the handles for manipulationof the guides. The handles can be joined together with a pivot, so thatpivoting the handles translates to a movement of the guides eithertoward or away from one another. The dilator may also have a ratchetinglock for maintaining the insertion spreader in a fixed position. Thepenetrating ends of the guides also may be sharpened to facilitatepenetrating the target tissue.

The dilator aspect of the invention also provides a method of creating atissue cavity by using the dilator. With the insertion spreader in theclosed position the spreader is advanced into the target tissue. Whenthe spreader reaches the desired depth the handles are moved to separatethe guides. The separation of the guides causes a tearing of the tissue,creating a cavity therein.

This method also may be employed by first advancing a needle partiallyinto the tissue to create an insertion path. The guides of the spreaderare positioned about the protruding part of the needle and inserted intothe tissue along the same path created by the needle.

This method for spreading tissue with the dilator of the invention maybe used to create a cavity in the vaginal hiatus. The term “vaginalhiatus” refers to the tissue between the urethra and the vagina. Thisterm may apply to the exterior surface between the distal urethra andthe vaginal orifice as well as to the deeper tissue between the urethraand the upper vaginal wall. In some cases spreading may be facilitatedby performing an episiotomy of the skin of the vaginal hiatus. Themethod of this aspect of the invention also may be performedtransvaginally to create a cavity, for example in the vaginal wall.Whatever the tissue, the method may be preceded with a fluid-dissectionof the target tissue, wherein a solution is injected into the tissue tocreate a fluid bolus. The fluid bolus forms a pocket in the tissue, andthe dilator is used to create an opening connecting the outer surface tothe pocket.

The invention also provides an insert card for advancing a medicaldevice, for example a urethral sling, into a tissue cavity. One end ofthe card holds the sling to be used for stabilizing tissue or internalstructures of the urethral or pelvic floor. The other end of the card isfashioned to permit a physician to grasp and manipulate the card, or toalign or connect the card with other external devices, such as thosedisclosed herein. The sides of the card may be adapted for use with thedilator mentioned above. Thus the card can be used to enhance both thesterility and the positional precision in a sling-placement procedure.

The card and the dilator may thus be used in a method of advancing asling into a tissue cavity. The tissue cavity is created by the dilatoras described above, and the spreader is locked in the open position. Asling is placed in the proper position on the card, and the card ispositioned so that its lateral edges align with and slide into thespreader guides. The spreader guides provide a track for the insertionof the card to the desired depth within the cavity. This method of slingplacement may be used in procedures employing a variety of techniquesfor securing the sling, including techniques adapted for slings that areto be secured with sutures, quick connect devices, bone anchors,staples, and the like.

Also provided in this invention is an incision guide for creating acavity between the urethra and the vagina. The incision guide has acatheter that is inserted into the urethra. This catheter expands andstraightens the urethra, essentially immobilizing the urethra in aneasily identified position. Also part of the incision guide is a cutterthat slides along the catheter and makes an incision into the vaginalhiatus that is a fixed distance from, and therefore parallel to, theurethra. The catheter may display graduation marks or other indicia toenable a surgeon to determine the position of the catheter or the cutterrelative to the bladder neck.

The incision guide of the invention may also have a stop, such as ablock or a ring, that locks in place on the catheter. The stop abuts thecutter and prevents insertion of the cutter beyond the desired depth ofincision.

The cutter portion of the incision guide may be a needle, a blade, abipolar knife, or other incision device adapted for slidably mounting tothe rigid catheter. One example of such an adapted incision device isthe dilator of the invention as described above.

The incision guide aspect of the present invention provides a method ofcreating a cavity in the vaginal hiatus. The method includes the stepsof inserting the catheter into the urethra, determining the position ofthe bladder neck by using the catheter, and inserting the attachedcutter into the vaginal hiatus. The catheter allows straight-linetracking for the cutter and indicates the depth of incision, thusavoiding injury to the bladder.

This method of creating a cavity in the vaginal hiatus may be used inconcert with the method of placing a sling in a cavity by use of thecard, as discussed above. The card supporting the sling may advance intothe cavity having its edges in contact with the hiatal tissue along thesides of the cavity. Alternatively the dilator of the invention also maybe used to serve as a guide for the card, after the cavity is made usingthe incision guide of the invention. When the card reaches the intendeddepth in the cavity, the sling is in proper position for fastening inplace.

An additional aspect of the present invention provides a driver fordriving a guide into or through the pubic bone. The driver has two jawsand a slide bar. The first jaw has a distal end that inserts into atissue cavity and a proximal end that attaches to the slide bar. Thesecond jaw slides along the slide bar toward the first jaw. The secondjaw has a bone-piercing guide attached to it such that the guide movestoward the first jaw when the second jaw is advanced along the slidebar. The guide connected to the driver may be a cannula, a needle, or alike device adapted for driving through bone.

The driver provides a method of driving a guide through the pubic bone.The steps include: inserting the first jaw of the driver into a tissuecavity, locating the pubic bone, positioning the driver to align thepubic bone between the first jaw and the second jaw, and advancing thesecond jaw toward the first jaw to drive the guide through the pubicbone.

The invention further provides a method for passing a device through thepubic bone. The guide is driven through the pubic bone as outlinedabove. The guide is next retracted, leaving a path through the bone, andthe device is passed through the pubic bone along the path made by theguide. The device passed by this method may be a suture, a suturepasser, a quick-connect fastening device, and the like.

In an additional method of this aspect of the invention, the driver ofthe invention is used to advance a cannula through the pubic bone. Thelumen of the cannula constitutes a channel through the pubic bone. Adevice may then be passed through the bone within the lumen of thecannula. Devices that may be passed by this method include a suture, asuture passer, a quick-connect fastening device, and the like.

A further method of pelvic surgery provided by the invention includesthe following steps. A cannula is driven through the pubic bone with thedriver of the invention. The cannula is further driven into the tissuecavity in which the first jaw of the driver is positioned. The first endof a suture is passed through the cannula and secured to a structurewithin the cavity. The second end of the suture is secured to the pubicbone, thereby stabilizing tissue adjacent to the cavity. According tothis method, the cannula may be removed from the bone before either endof the suture is secured, or the suture within the tissue cavity may besecured before withdrawal of the cannula. The suture within the tissuecavity may be secured by stitching the suture through a tissue mass ofthe cavity, or by attaching the suture to a structure introduced intothe cavity for stabilizing the tissue of the cavity, such as a suturebutton.

The invention also provides a method of pelvic surgery wherein a cannulais driven through the pubic bone and into the tissue cavity as describedabove, and a suture is passed through the cannula and into the cavity.The suture is passed through a structure therein to stabilize the tissueadjacent to the cavity, then the suture is passed back out along thesame path through the bone, and both ends of the suture are secured tothe pubic bone.

Yet another method of the invention involves driving a cannula throughthe pubic bone and into a tissue cavity in a first location to make afirst path. The suture is then advanced into the cavity along the firstpath. The suture is passed through a structure of the cavity tostabilize the tissue adjacent to the cavity. The cannula is then driventhrough the bone and into the cavity along a second path, and the sutureis withdrawn from the cavity along the second path. Both ends of thesuture are then secured to the pubic bone.

The foregoing methods focus on the path of the suture: the suture may beadvanced one-way into the cavity and affixed there, or the suture may beadvanced and withdrawn from the cavity along the same path through thebone, or the suture may be advanced and withdrawn along two separatepaths through the bone. Regardless which method is used, the tissuecavity of the method may be the vagina. Alternatively, the cavity may bea hiatal cavity made according to a method of the dilator or incisionguide aspects of the present invention. Further, the tissue cavity ofthe method may be a transvaginally created pocket into the plane of thevaginal hiatus. Also regardless which method is used, the method mayadvantageously be performed on the left side of the cavity and on theright side of the same cavity by piercing the pubic bone on both sideslateral to the pubic symphysis. The method may also include a step oftensioning the suture to elevate or otherwise stabilize the tissue mass.

Further provided is a method of stabilizing a urethral sling relative tothe pubic bone. This is done by creating a tissue cavity and creating apath through the pubic bone by driving a guide through the bone. Then aurethral sling is placed into the cavity. A suture is passed through thepubic bone along the path, and is attached to the tissue mass. Thesuture is then secured to the pubic bone to stabilize the tissue.

Another aspect of the invention provides a driver frame assembly forpositioning and stabilizing a bone-piercing guide driver relative to thepatient. The driver frame assembly includes an upper clamp and a lowerclamp, as well as a catheter, a cavity tongue, and the driver. The upperclamp has a head portion, a descending arm, and a base portion. The headportion has a compression foot for compressing the patient's abdominalsurface against the pubic bone. Stabilizing pins extend downward fromthe compression foot and penetrate the abdominal surface adjacent to thesuperior surface of the pubic bone. The base portion of the upper frameattaches to the catheter and the tongue. The catheter is used to expandand straighten the urethra; the tongue inserts into the cavity,providing counterpressure to oppose the pressure of the compressionfoot. The lower clamp has a buttock plate for insertion beneath thepatient, so that the patient's weight rests on the plate to secure theframe assembly relative to the patient. The lower clamp also has anascending arm that connects with the base portion of the upper clamp.

Finally, at least one driver is attached to the descending arm of theupper clamp. There may be more than one driver mounted to the frameassembly, or there may be one driver that drives two bone-piercingguides, which may be displaced to the left and right of center relativeto the patient.

This aspect of the invention provides a method for stabilizing pelvictissue by relatively non-invasive pelvic surgery. The foregoing frameassembly is installed on the patient. The bone-piercing guide ispositioned and is driven through the bone and into the cavity. Astabilizing device is passed along the path through the bone created bythe guide and secured in the cavity, thus stabilizing the targetedtissue of or adjacent to the cavity. This method may employ two or moreguides, or one guide in various positions, to create more than one paththrough the pubic bone. The path created may be directly through thebone, after removal of the guide, or may be through the guide itself, ifthe guide is a cannula.

The stabilizing device thus passed through the bone may be a suture, asuture passer, a quick connect device, and the like. The cavity may bethe vagina, a cavity of the vaginal hiatus, or a cavity made by entrythrough the vaginal wall. The method of stabilization may be a suturestitching of the cavity tissue or the placement of a quick connectdevice to a sling or suture button. The tissue stabilization is achievedby securing the suture to the bone with a quick-connect bone suturefastener. A sling, suture button, or like device that attaches to thesuture or quick connect may be positioned in the tissue cavity by usingthe card discussed above in cooperation with the frame. The tongue ofthe frame may be adapted to cooperate with the card much like thedilator of the invention, such that the proper placement of the tongueas part of frame installation assures proper positioning of the deviceto be carried on the card for binding the device to a suture or a quickconnect device. This card may be advanced into position in a cavity ofthe vaginal hiatus, the vagina, or a cavity made in the vaginal wall.

Another aspect of the invention provides a system for attaching aurethral sling to a suture. The system includes a urethral sling and aconnector. Part of the sling is a ring member. The ring member has acentral opening that cooperates with the sling to allow unidirectionalpassage of the connector through the opening, and to prevent retrogradepassage of the connector through the opening. The connector and ringmember may have a variety of configurations. One such configurationprovides a ring member having several flanges and a substantiallyconical connector with a shoulder that contacts the flanges, preventingwithdrawal of the connector from the ring member. Another configurationprovides a connector having an elongate axial segment and a leadingsegment that is flexibly perpendicular to the axial segment. This “T”connector may cooperate with a ring member that is simply an opening inthe urethral sling. The connectors of any configuration may be aattached to a suture.

This aspect of the invention provides a method for securing a sling forurethral and pelvic floor reconstruction. A sling having a suitable ringmember is placed in position in a tissue cavity. A suture with asuitable connector is passed through the pubic bone, and the connectoris advanced through the ring member of the sling. The suture is thenfastened to the pubic bone, thus securing the sling in the cavity. Thecavity may be the vagina, a cavity of the vaginal hiatus, or a cavity inthe vaginal wall.

A closely related aspect of the invention provides a system forattaching a securing device to a suture. The system includes a securingdevice with a ring member, and a connector that attaches to a suture.The ring member and the connector cooperate as described above. Thesecuring device may be a suture button, a staple, or a quick connect.

The method provided in this aspect of the invention is a method forsecuring a target tissue to the pubic bone. The securing device with aring member is placed within or adjacent to the target tissue. A suturewith a suitable connector is passed through the pubic bone, and theconnector is advanced through the ring member of the securing device.The suture is fastened to the pubic bone, thus securing the targettissue to the bone.

Also part of the present invention is a bone eyelet having a sleeve andat least one crosspiece. The sleeve has an outer surface and an innersurface. The outer surface is adapted for inserting into a bone, and thecrosspiece is attached to the inner surface to transect the sleeve,providing a plurality of channels in the sleeve. The crosspiece may be aplane or a rod. Alternatively, the crosspiece may be created by apiercing or crimping of the sleeve. The sleeve may have an externalfriction surface for contacting with the bone. It may have a flange rimfor suspending the sleeve at the surface of the bone. The sleeve mayalso have a conical shape to facilitate advancing the sleeve into andcontacting it with the bone.

The invention provides a method for securing a suture to a bone. Thebone is pierced and a suture is passed through the bone. Suture ends arepassed through at least two channels in the bone eyelet and the boneeyelet is placed in the opening in the bone. The suture ends are thentied, thus securing the suture to the bone. The bone may be pierced witha drill or with a driver as described above. The suture may be connecteddirectly to a tissue or to a medical device, such as a sling, a quickconnect device, a suture button, a staple, an implant, or to itself.Appropriate tension on the suture may be provided, for example with useof a suture tensioner.

The invention also provides a quick-connect bone suture fastener forfastening suture to a bone. The suture fastener consists of a sleeve anda sleeve plug. The sleeve has at least two openings through which suturemay pass. The sleeve is adapted for inserting into a bone, and has asurface for frictionally contacting the sleeve plug, which functions toocclude at least one of the openings. The friction surface of the sleevemay be threaded for contacting with a threaded sleeve plug; the frictionsurface also may be a plurality of flanges that overlie the top of thesleeve plug after the plug is inserted into the sleeve. There also maybe a friction surface on the outside of the sleeve for contacting withthe bone. The sleeve may have a flange rim for suspending the sleeve atthe surface of the bone. The sleeve may also have a conical shape tofacilitate advancing it into and contacting it with the bone.

This aspect of the invention provides a method for quick connection of asuture to a bone. A bone is pierced and a suture is passed through thebone and through the sleeve. The sleeve is then pressed into the openingin the bone. The sleeve plug is then inserted into the sleeve, and thesuture is secured. The bone may be pierced by drilling or by driving aguide through the bone. The suture may be attached to tissue or to adevice, as described above. The suture may be tensioned with a suturetensioner prior to placement of the sleeve plug.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of a guide member placementdevice having a male connector at the distal end of the shaft.

FIG. 2 is an assembled cross-sectional view of the guide memberplacement device of FIG. 1 showing the internal structure of the device.

FIG. 3 is a side view of an embodiment of a guide member placementdevice having a female connector at the distal end of the shaft.

FIG. 4 is an enlarged cross-sectional view taken along line 4-4 of thedistal end of the shaft of a guide member placement device of FIG. 1.

FIG. 5 is an enlarged cross-sectional view taken along line 5-5 of thedistal end of the shaft of the guide member placement device of FIG. 3.

FIG. 6 is a cross-sectional view showing the distal ends of the shaftsof the guide member placement devices of FIGS. 1 and 3 coupled throughtheir male and female connectors.

FIG. 7A is an enlarged view of the distal portion of the shaft of theguide member placement device taken along line 7A-7A of FIG. 1.

FIG. 7B is an enlarged view of the distal portion of the shaft of theguide member placement device taken along line 7B-7B of FIG. 3.

FIG. 7C is an enlarged view of the distal portion of the shaft of aguide member placement device having an alternate shaft configuration inwhich the curve is smoothly curved.

FIG. 7D is an enlarged view of the distal end of the shaft of a guidemember placement device having an alternate shaft configuration in whichthe curve is smoothly curved.

FIG. 8 shows the blunt dissection tip extending into a tissue from thedistal end of the shaft of a guide member placement device having a maleconnector to create an opening in the tissue.

FIG. 9 shows a first guide member placement device that has beeninserted into a first suprapubic incision and advanced into the bodytissue.

FIG. 10 shows a guide member placement device that has been advancedinto the tissue between the urethra and the upper vaginal wall such thatthe distal end of the shaft extends transversely between the urethra andthe upper vaginal wall in the plane defined by the longitudinal axes ofthe urethra and the vagina.

FIG. 11 shows the blunt dissection tip extending into a tissue from thedistal end of the shaft of a guide member placement device having afemale connector to create an opening in the tissue.

FIG. 12 shows a second guide member placement device that has beeninserted into a second suprapubic incision and advanced into a bodytissue.

FIG. 13 shows the first and second guide member placement devices in thetissue between the urethra and the upper vaginal wall with the distalends of their shafts connected to one another.

FIG. 14 shows a guide member extending between the two suprapubicincisions after removal of the first and second guide member placementdevices.

FIG. 15 is a plan view of a sling application catheter.

FIG. 16 is an enlarged view of the distal end of the sling applicationcatheter taken along line 16-16 of FIG. 15.

FIG. 17 is a cross-sectional view taken along line 17-17 of the slingapplication catheter of FIG. 16.

FIG. 18 is an enlarged view of the distal end of a sling applicationcatheter having a reinforcing stiffener within the pouch.

FIG. 19 is a cross-sectional view taken along line 19-19 of the slingapplication catheter of FIG. 18.

FIG. 20 is an enlarged view of the distal end of a sling applicationcatheter having a pouch made of a porous material.

FIG. 21 shows a sling application catheter being inserted into a firstsuprapubic incision with a guide member extending through the lumen ofthe catheter.

FIG. 22 shows the sling being withdrawn from the pouch of a slingapplication catheter that has been advanced into the tissue between theurethra and the upper vaginal wall.

FIG. 23 shows the sling extending between the first and secondsuprapubic incisions and passing through the tissue between the urethraand the upper vaginal wall.

FIG. 24 is a plan view of a tissue dissector/dilator in which the springreturn button is at the most proximal point and the blunt dissection tipand the expandable balloon are retracted within the shaft.

FIG. 25 is a plan view of the tissue dissector/dilator in which thespring return button has been advanced to the locked position and theexpandable balloon and blunt dissection tip are fully extended from theshaft.

FIG. 26 is a side view of a balloon catheter with a blunt dissection tipat its distal end.

FIG. 27 is a plan view of a tissue dissector/dilator in which the springreturn button has been advanced towards the distal end of the slide andthe blunt dissection tip extends from the shaft.

FIG. 28 is a plan view a tissue dissector/dilator in which the triggerhas been squeezed, causing the balloon to inflate.

FIG. 29 is a plan view of an alternate embodiment of the tissuedissector/dilator.

FIG. 30 shows the distal end of the shaft of a tissue dissector/dilatorbeing advanced until it intersects the tissue between the urethra andthe upper vaginal wall at approximately mid-thickness and in a directionwhich would permit the expandable balloon to advance perpendicular tothe axial direction of the urethra.

FIG. 31 shows the blunt dissection tip being extended from the distalend of the shaft into the tissue between the urethra and the uppervaginal wall thereby dissecting a first opening in the tissue.

FIG. 32 shows the expandable balloon extended into the first opening inthe tissue between the urethra and the upper vaginal wall which wascreated with the blunt dissection tip.

FIG. 33 shows the balloon being expanded in the first opening in thetissue thereby dilating the first opening.

FIG. 34 shows a second tissue dissector/dilator with its blunt tipdissecting a second opening in the tissue between the urethra and theupper vaginal wall which is aligned with the first opening in thetissue.

FIG. 35 shows the expandable balloon extended into the second opening.

FIG. 36 shows the expandable balloon expanded within the second openingthereby dilating the body tissue.

FIG. 37 shows a continuous opening in the tissue between the urethra andthe upper vaginal wall.

FIG. 38A is a perspective view of a sling application device.

FIG. 38B is a plan view taken along line 3813-3813 of the slingapplication device of FIG. 38A showing the tab on the locking button.

FIG. 39 is a side-view of the sling application device.

FIG. 40 is a cross-sectional view taken along line 40-40 of the firstshaft of the sling application device of FIG. 39.

FIG. 41 is a cross-sectional view taken along line 41-41 of the secondshaft of the sling application device of FIG. 40.

FIG. 42 is a side view of an alternate embodiment of the slingapplication device in which the portion of the shafts proximal to thebend is cylindrical and the portion of the shafts distal to the bend isa flat tube.

FIG. 43 is a cross-sectional view taken along line 43-43 of the portionof the first shaft distal to the bend of the sling application device ofFIG. 42.

FIG. 44 is a cross-sectional view taken along line 44-44 of the portionof the first shaft proximal to the bend of the sling application deviceof FIG. 42.

FIG. 45 is a side view of an alternate embodiment of the slingapplication in which the shafts are flat along their entire length.

FIG. 46 is a cross-sectional view taken along line 46-46 of the firstshaft of the sling application device of FIG. 45.

FIG. 47 is a side view of an alternate embodiment of the slingapplication device in which the shafts have a side bend.

FIG. 47A is a plan view of the first shaft taken along line 47A-47A ofthe sling application device of FIG. 47.

FIG. 47B is a plan view of the second shaft taken along line 4713-4713of the sling application device of FIG. 47.

FIG. 48 is a side view of a sling application device in which the shaftshave a 90° twist.

FIG. 49 is a perspective view of the distal ends of the first and secondshafts of a sling application device in which the upper edges of thedistal ends of the shafts are slightly indented relative to the loweredges.

FIG. 50 is a side view of an obturator for use with the slingapplication device.

FIG. 51 is a plan-view of a sling introducer.

FIG. 52 is a cross-sectional view taken along line 52-52 of the slingintroducer of FIG. 51.

FIG. 53 is a cross-sectional view of a cutter showing the internalstructure of the device.

FIG. 54 shows the first shaft of the sling application device beingadvanced into a pre-formed opening in the tissue between the urethra andthe upper vaginal wall.

FIG. 55 shows the distal ends of the first and second shafts of thesling application device opposing each other in the opening in tissuebetween the urethra and the upper vaginal wall.

FIG. 56 shows the first and second handles of the sling applicationdevice locked together.

FIG. 57 shows the distance between the distal ends of the first andsecond shafts of the sling application device being decreased as theadjuster is advanced to a position in between the proximal point and thedistal point of the guide.

FIG. 58 shows the tissue between the distal ends of the first and secondshafts of the sling application device being compressed when theadjuster is advanced to the distal end of the guide.

FIG. 59 shows an opening in the tissue between the urethra and the uppervaginal wall being created by a cutter dissecting the tissue between thedistal ends of the first and second shafts of the sling applicationdevice.

FIG. 60 shows the sling introducer being inserted into the second shaftof the sling application device.

FIG. 61 shows the sling being withdrawn from the sling introducer as thesling introducer is advanced through the tissue between the urethra andthe upper vaginal wall.

FIG. 62 shows the sling fully withdrawn from the sling introducer andlocated within the first and second shafts of the sling applicationdevice.

FIG. 63 shows the second shaft of the sling application device beingremoved from the patient's body.

FIG. 64 shows the first shaft of the sling application device beingremoved from the patient's body.

FIG. 65 shows the sling extending between the suprapubic incisions andpassing through the tissue between the urethra and the upper vaginalwall.

FIG. 66 is a side view of a detachable member sling application device.

FIG. 67 is a side view of a retrieval device.

FIG. 68 shows the creation of an opening in the tissue between theurethra and the upper vaginal wall by hydrodissection.

FIG. 69 shows the shaft of a detachable member sling application devicesling application device being advanced to a pocket or opening in thetissue between the urethra and the upper vaginal wall.

FIG. 70 shows the sharpened point of the needle of the detachable membersling application device extending through the upper vaginal wall.

FIG. 71 shows the needle of the detachable member sling applicationdevice being secured on the vaginal side with a hemostat.

FIG. 72 shows the detachable cup being detached from the distal end ofthe shaft of the detachable member sling application device.

FIG. 73 shows the needle of the detachable member sling applicationdevice being toggled.

FIG. 74 shows the shaft of a retrieval device being advanced through asecond suprapubic incision into the pocket.

FIG. 75 shows the shaft of the retrieval device being inserted into thedetachable cup and engaging the detachable cup.

FIG. 76 shows the needle being removed from the vagina.

FIG. 77 shows the sutures connected to the sling being pulled out of theshaft of the detachable cup sling application device.

FIG. 78 shows the shaft of the retrieval device being withdrawn from thepocket or opening, pulling the sling out of the shaft of the detachablemember sling application device.

FIG. 79 shows the shafts of the retrieval device and the detachablemember sling application device being withdrawn from the pocket.

FIG. 80 shows the sling located in the opening in the tissue between theurethra and the upper vaginal wall with the sutures extending throughthe incisions to the outside of the patient's body.

FIG. 81 shows the marks on the sutures being aligned to ensure centeringof the sling beneath the urethra within the opening in the tissuebetween the urethra and the upper vaginal wall.

FIG. 82 is a side view of a balloon catheter having two expandableballoons joined at their distal ends.

FIG. 83 shows the balloon catheter of FIG. 82 with the balloonsexpanded.

FIG. 84 is a plan view of the balloon catheter having a flat profileballoon.

FIG. 85 is a cross-sectional view taken along line 85-85 of the ballooncatheter of FIG. 84.

FIG. 86 is a cross-sectional view taken along line 86-86 of the ballooncatheter of FIG. 84.

FIG. 87 is a cross-sectional view of a tissue expander.

FIG. 88 is a side view of a grasping device.

FIG. 89 shows the target site for insertion of a device for creating alumen in the hiatal tissue between the urethra and the upper vaginalwall.

FIG. 90 shows the urethra straightened with a Foley catheter.

FIG. 91 shows a large bore needle being inserted into the hiatal tissuebetween the urethra and the upper vaginal wall.

FIG. 92 shows the needle partially retracted such that the lumen createdby the needle provides an access channel.

FIG. 93 shows a balloon catheter being advanced beyond the tip of theneedle into the lumen created in the hiatal tissue.

FIG. 94 shows the balloon of the balloon catheter being inflated todilate the tissue around the lumen created in the hiatal tissue.

FIG. 95 shows the tissue expander being advanced beyond the tip of theneedle into the lumen created in the hiatal tissue.

FIG. 96 shows the tissue expander in the expanded configuration withinthe lumen created in the hiatal tissue.

FIG. 97 shows a suture passing through the expansion basket of thetissue expander and into the self expanding basket of the graspingdevice.

FIG. 98 shows the grasping device grasping the suture.

FIG. 99 shows the grasping device being withdrawn from the rigid tubeand drawing the suture towards the outside of the patient's body.

FIG. 100 shows the urethra, the vaginal wall and the vagina intransverse cross section.

FIG. 101 a represents the insertion of a needle into the vaginal hiatus.

FIG. 101 b illustrates the insertion of a dilator into the vaginalhiatus over the needle of FIG. 101 a.

FIG. 101 c depicts the withdrawal of the needle of FIG. 101 a andfurther insertion of the dilator of FIG. 101 b.

FIG. 101 d represents the dilator of FIG. 101 c in the open position.

FIG. 101 e illustrates the alignment of the insert card with the guidesof the dilator of FIG. 101 d.

FIG. 101 f shows the insertion of the insert card between the guides ofthe dilator of FIG. 101 d.

FIG. 101 g shows the insert card in position in the hiatus afterwithdrawal of the dilator.

FIG. 102 is a partial longitudinal cross section of the vagina, urethra,and bladder showing a rigid catheter in place in the urethra.

FIG. 103 is a cross section as in FIG. 102, and shows a rigid catheterwith the stop attached.

FIG. 104 is a cross section as in FIG. 102, and shows an incision guideassembly with a catheter, stop, and cutter in place.

FIG. 105 a is a transverse cross section taken along the line 105-105 inFIG. 104 and illustrates the hiatal region of the patient with thecatheter in place and the cutter as a needle.

FIG. 105 b is a transverse cross section as in FIG. 105 a and shows thehiatal region with the catheter in place and the cutter as a blade.

FIG. 106 is a cross section view of the pelvis as in FIG. 102 with thedriver positioned above the pubic bone.

FIG. 107 is a cross section including a driver as in FIG. 106, depictingthe passage of the bone-piercing guide through the pubic bone lateral tothe urethra and into the vagina.

FIG. 108 a is a transverse cross section taken along the line 108-108 inFIG. 107, showing the distal end of the first jaw of the driver inposition in the vagina, with cannulas forming a passage through thepubic bone and into the vagina.

FIG. 108 b is a cross section as in FIG. 108 a that illustrates passagethrough the cannulas of a suture and connecting device.

FIG. 109 a is a cross section as in FIG. 108 a, showing the pubic bone,the urethra, the hiatal region and the vagina, with sutures attached onthe right and left sides of the upper vaginal wall.

FIG. 109 b is a cross section as in FIG. 109 a, showing elevation of theurethra resulting from tensioning of the sutures.

FIG. 110 is a cross section view of the pelvis as in FIG. 102 with theupper clamp of the driver frame assembly in place, articulating with therigid catheter and the tongue.

FIG. 111 a is a cross section taken along the line 111-111 in FIG. 110,and illustrates the hiatal region depicting a flat insertion tongue.

FIG. 111 b is a cross section taken along the line 111-111 in FIG. 110,and depicts a concave insertion tongue in a hiatal cavity.

FIG. 111 c is a cross section taken along the line 111-111 in FIG. 110,and depicts an additional embodiment of a concave insertion tongue in ahiatal cavity.

FIG. 112 is a cross section view of the pelvis as in FIG. 102 showingthe complete driver frame assembly in place.

FIG. 113 is a cross section view taken along the line 113-113 in FIG.112, showing left and right displacement of the bone-piercing guidesmounted on the driver.

FIG. 114 is a cross section as in FIG. 102, and depicts the driver frameassembly with the bone-piercing guides penetrating to the hiatal cavity.

FIG. 115 illustrates the pubic bone with the guides passing through thebone left and right of the pubic symphysis.

FIG. 116 is a cross section view of the pelvis as in FIG. 102 and thedriver frame, with the tongue supporting an insert card and a sling inposition.

FIG. 117 is a cross section taken along the line 117-117 in FIG. 116,and shows the position of the rigid catheter inside the urethra, thetongue, the insert card, and the sling.

FIG. 118 is a cross section as in FIG. 116 with the driver frame inplace, and shows the driver frame with the driver removed and a cannulain position.

FIG. 119 corresponds to FIG. 118, but shows the driver frame with thecannula in place and a suture with quick-connect device passing throughthe cannula.

FIG. 120 is a detail view of the area described by the curved arrows inFIG. 119, and shows detail of the quick-connect device passing throughthe cannula toward the sling.

FIG. 121 corresponds to FIG. 120, and provides detail of thequick-connect device articulating with the ring member of the sling.

FIG. 122 is a cross section taken along the line 122-122 in FIG. 121,and shows the position of the rigid catheter, left and right sidecannulas, and a quick-connect device in the left cannula articulatedwith the ring member of the sling.

FIG. 123 a illustrates in cross section the position of the concaveinsertion tongue with contact pins relative to the urethra, the pubicbone, and the compression foot of the driver frame assembly, prior toapplication of counterpressure on the pubic bone by the concave tongue.

FIG. 123 b corresponds to FIG. 123 a and shows the concave tongue andcontact pins providing counterpressure against the inferior posteriorface of the pubic bone.

FIG. 124 is a view of the insertion tongue from the direction 124-124 ofFIG. 123 a, and provides detail of the elevated edge of the concaveinsertion tongue, showing the position of the contact pins and thepassage gap.

FIG. 125 a corresponds to FIG. 123 b, and shows the compression footwith bone driver guides passing through the pubic bone and passage gapof the tongue.

FIG. 125 b corresponds to FIG. 125 a, and shows the withdrawal of theguides and the position of the sutures.

FIG. 126 a corresponds to FIG. 125 b, and shows the orientation of thesutures, the tongue, and the hiatal cavity before tensioning of thesutures.

FIG. 126 b corresponds to FIG. 126 a, and shows the elevation of thehiatal cavity and the urethra after tensioning of the sutures.

FIG. 127 is a cross section view as in FIG. 102 showing a sling with thering member of a quick-connect device in place.

FIG. 128 is a plan view of a sling with the ring member of aquick-connect device in place.

FIG. 129 is a cross section view taken along the line 129-129 in FIG.128, showing the sling with the quick-connect ring member in place.

FIG. 130 is a plan view showing the bone eyelet in position in a bonewith suture on either side of the crosspiece.

FIG. 131 is a cross section taken along the line 133-133 in FIG. 130,and depicts the bone eyelet with a planar crosspiece in position in thepubic bone and connected by suture to an arrowhead configuration of thequick-connect device articulated with the ring member of the sling.

FIG. 132 corresponds to FIG. 131, but shows a bone eyelet with a rodcrosspiece in place in the pubic bone connected via suture to aT-configuration of the quick-connect device.

FIG. 133 is a perspective view of the T-configuration of thequick-connect device.

FIG. 134 is a side elevation that depicts the passage of theT-configuration of the quick-connect device through a cannula toward thering member of a sling.

FIG. 135 is a perspective view of a bone suture fastener and a sleeveplug oriented above the pubic bone.

FIG. 136 a is a cross-section taken along the line 136-136 in FIG. 135and illustrates suture passing through the sleeve with the sleeve plugin place.

FIG. 136 b is a cross section view similar to FIG. 136 a showing thezipper-lock configuration of the bone suture fastener with the sleeveplug in place.

FIG. 137 is a cross section view similar to FIG. 136 a showing thethreaded configuration of the bone suture fastener with the sleeve plugin place.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Part A

The present invention relates to methods and devices for creatingopenings or pockets in body tissues and/or dilating body tissues. Theguide member placement devices, sling application catheters, tissuedissector/dilators, sling application devices, sling applicationsystems, detachable member sling application devices, retrieval devices,and balloon catheters of the present invention may be usedpercutaneously or in conjunction with laparoscopic techniques. In suchlaparoscopic procedures, trocars are placed in the abdomen and theabdomen is insufflated with CO2, causing it to distend. The devices areintroduced into the patient's body via the trocars, and the procedure isvisualized with a laparoscope.

The devices of the present invention may be used in a wide variety ofmedical procedures, but are particularly well suited for urethral floorreconstruction procedures such as bladder neck stabilization orsuspension procedures in which a sling is used to maintain or improveurinary continence by stabilizing and/or slightly compressing theurethra or by creating a non-moveable pelvic floor. Slings suitable foruse in bladder neck stabilization procedures and methods for implantingthem are disclosed in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

The present invention is particularly well suited for bladder neckstabilization procedures for treating urinary incontinence in females.The bladder neck stabilization procedures for which the presentinvention is especially well suited involve the creation of an openingor pocket in the tissue between the urethra and the upper vaginal wall,which is called the hiatus. The sling is then inserted in the opening orpocket. Sutures or integral attachment members at the ends of the slingare attached to the pubic bone or surrounding tissue and the tension isadjusted to slightly compress or stabilize the urethra by providing aplatform to reduce distension resulting from internal pressures, therebymaintaining or improving urinary continence. Suitable methods anddevices for adjusting the tension on the sutures are disclosed in U.S.Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosure of which is incorporated herein by reference.

The opening or pocket may be created in a variety of ways. In oneapproach, the opening or pocket is created by introducing an expandableballoon into the tissue between the urethra and the upper vaginal wall.When the balloon is expanded, the surrounding tissue is dilated or torn,generating an opening or pocket of sufficient size to receive the sling.

In an alternative approach, the opening or pocket is created byhydrodissection. In this approach, a bolus of saline or other sterilesolution is injected into the tissue between the urethra and the uppervaginal wall, resulting in an opening or pocket sized to receive thesling. The bolus of saline may be administered by positioning a syringeinside the vagina and piercing the vaginal wall with the needle of thesyringe such that the tip of the needle is in the tissue between theurethra and the upper vaginal wall. Alternatively, the bolus of salinemay be administered directly into the hiatal tissue without piercing thevaginal wall.

The volume of saline injected into the tissue in the hydrodissectionprocedure is too large to be rapidly absorbed such that the tissue mustseparate to accommodate the saline bolus. Preferably, the volume ofsaline introduced into the tissue is from about 4 cc to about 10 cc.More preferably, the volume of saline is about 4 to about 5 cc.

In yet another approach, the opening or pocket is created by dissectingthe tissue between the urethra and the upper vaginal wall with acombination of blunt dissectors and sharp cutters.

The opening or pocket may be created and the sling may be introduced bytaking a variety of routes through the patient's body. In one approach,called the percutaneous approach, the opening or pocket is created bymaking suprapubic incisions into which a device for introducing anopening or pocket in a body tissue or dilating a body tissue isinserted. The device is advanced through the patient's body tissue intothe tissue between the urethra and the upper vaginal wall where theopening or pocket is to be created. In some instances, the device forintroducing an opening or pocket in a body tissue or dilating a bodytissue may also introduce the sling into the opening.

In another approach, called the hiatal approach, the opening or pocketis created and the sling is introduced by directly accessing the tissuebetween the urethra and the upper vaginal wall. In this procedure theopening or pocket can be created without making suprapubic or vaginalincisions.

In other approaches, the opening or pocket is created directly in thetissue between the urethra and the upper vaginal wall and the sling isintroduced with a device advanced into the opening or pocket from asuprapubic or vaginal incision.

The devices and procedures described briefly above are discussed ingreater detail in the following sections. It will be appreciated bythose of skill in the art that any of the disclosed devices and methodsfor creating an opening or pocket can be combined with any of thedisclosed devices and methods for introducing a sling into the openingor pocket.

Guide Member Placement Device

One aspect of the present invention relates to methods in which thesling is introduced over a guide member and devices for use in suchmethods. The guide member may be a suture, guidewire, or other structuresuitable for guiding a sling to a desired location.

In one embodiment, the opening or pocket in which the sling isintroduced is created first and the guide member is then passed throughthe opening or pocket. In this embodiment, the opening or pocket may becreated using any of the techniques disclosed herein, includingexpandable balloons and hydrodissection.

Alternatively, the opening or pocket may be created during guide memberplacement by extending and retracting a blunt dissector on a guidemember placement device.

In yet another embodiment, the opening or pocket in which the sling isintroduced is created by the sling application catheter disclosed hereinafter the guide member is positioned.

Devices and methods for using a guide member to introduce a sling in thetissue between the urethra and the upper vaginal wall will now bediscussed in greater detail.

One aspect of the present invention relates to guide member placementdevices for applying a guide member under the urethra in a less invasivemanner without puncturing the vaginal wall.

In general, the guide member placement device comprises a shaft having aproximal end, a distal end, and a lumen extending therethrough. Thelumen is adapted for receiving a guide member.

Preferably, the shaft is rigid. It is also preferred that the proximalend of the shaft is attached to a handle having a lumen extendingtherethrough. Preferably, the guide member placement device has a bluntdissection tip with a lumen extending therethrough. The blunt dissectiontip is preferably located at the distal end of the shaft. It is alsopreferred that the blunt dissection tip is on a blunt dissector which iswithin the shaft and is extendable from and retractable in the shaft.

Preferably, the lumen in the blunt dissector is in fluid communicationwith the lumen in the handle. Preferably, the blunt dissector is axiallymovable and can be extended from and retracted in the shaft. Preferably,the blunt dissector is made of rigid plastic or flexible metal. Forexample, the blunt dissector may be a coil of stainless steel. The bluntdissector may be solid and may be made of metals such as stainlesssteel, spring steel, Elgiloy, Nitinol, or other generally elasticmetals. The blunt dissector may also be a rigid plastic such as nylon orAcrylonitrile Butadiene Styrene (ABS).

The guide member placement device has an engaging member at the distalend of the shaft which is complementary to or otherwise adapted to beattached to an engaging member at the distal end of the shaft of asecond guide member placement device, such that the shafts of the twoguide member placement devices can be attached to one another with thelumens of the blunt dissectors in each shaft in fluid communication withone another.

Referring to FIGS. 1, 2 and 3, there are disclosed guide memberplacement devices 10, 1910 in accordance with one aspect of the presentinvention. Handle 12, 1912 serves both as a gripping area for thephysician and as a support structure for the guide member placementdevice. Handle 12, 1912 preferably comprises a hollow tubular body 13,1913. The handle 12, 1912 is preferably of such a size to be easilygripped by a user. For instance, in one embodiment, the handle isapproximately 0.75 inches (20 mm) in diameter and approximately 4 inches(110 mm) in length. Preferably, handle 12, 1912 is provided withknurling or other surface texturing to produce a high friction grippingsurface.

A support 20, 1920 is preferably mounted such that it extends from thedistal end of the handle 12, 1912 to provide a mounting support for theshaft 22, 1922. The support 20, 1920 acts as a transition member fromthe handle 12, 1912 to support the shaft 22, 1922.

The shaft 22, 1922 is an elongate member with its proximal end insertedwithin or secured to the support 20, 1920. The shaft 22, 1922 may beattached to the support 20, 1920 in any variety of manners, includingbrazing, threading or other means well known to those of skill in theart.

The shaft 22, 1922 extends distally from the support 20, 1920 and ispreferably within the range of from about 6 inches to about 10 inches inlength.

The shaft 22, 1922 has a lumen 30 extending therethrough. A preferredembodiment of the distal end of the shaft is shown in FIGS. 7A and 7B.In this embodiment, the shaft 22, 1922 has a straight proximal section23, 1923, a bent intermediate section 25, 1925, and a distal end 27,1927. In an alternate embodiment, the shaft 2122, 2222 may be smoothlycurved as shown in FIGS. 7C and 7D. In the embodiments of FIGS. 7A-7D,the distal end of the shaft is preferably oriented at an angle of 90°relative to the straight proximal section of the shaft. Preferably, thecurve of the shaft is smooth to facilitate movement of the bluntdissector 32 within the shaft.

As will be understood by one of skill in the art, the dimensions andcurvature of the shaft 22, 1922 may vary depending on anatomicalconsiderations and the type of procedure in which it is intended to beused.

The distal ends 27, 1927 of the shafts 22, 1922 of the guide memberplacement devices 10, 1910 are provided with engaging members 28, 1928which are complementary to each other, such that the shafts 22, 1922 ofthe two guide member placement devices 10, 1910 are adapted to beattached to one another. In one embodiment of the guide member placementdevice 10, depicted in FIGS. 1 and 2, the engaging member comprises amale connector 17 as illustrated in the enlarged cross-sectional view ofFIG. 103. The male connector 17 on the guide member placement device 10shown in FIGS. 1 and 2 is complementary to the female connector 1915 onthe guide member placement device 1910 shown in FIG. 3 and shown in theenlarged cross-sectional view in FIG. 4. As shown in the enlargedcross-sectional view of FIG. 6, the male connector 17 on the guidemember placement device 10 of FIGS. 1, 2 and 4 engages the femaleconnector 1915 on the guide member placement device 1910 of FIGS. 3 and5 and attaches the two guide member placement devices 10, 1910 togethersuch that the lumens 42, 1942 of the blunt dissectors 32, 1932 of eachof the two devices are in fluid communication with one another. Whendesired, the male connector 17 disengages from the female connector1915, permitting the two guide member placement devices 10, 1910 to beseparated.

While the complementary engaging members 28, 1928 of the embodimentsshown in FIGS. 1-5 are male and female connectors, those skilled in theart will appreciate that a number of alternative configurations can beemployed for the engaging members, and the present inventioncontemplates such alternative configurations.

FIG. 2 is a cross-sectional view showing the internal structure of theguide member placement device 10 having a male connector at the distalend of the shaft. The internal structure of the embodiment of the guidemember placement device 1910 having a female connector at the end of theshaft is similar to that shown in FIG. 2. Thus, the internal structurewill only be described with respect to the device having a maleconnector.

As shown in FIG. 2, the handle 12 has a proximal end wall 14 and adistal end wall 16. The support 20 as illustrated is provided with agenerally cylindrical proximal section 24 for engagement within thedistal end of the handle 12 and a tapered distal section 26 for securingthe shaft.

The shaft 22 is preferably no more than about 0.1 inches (2.5 mm) indiameter and is provided with at least one central lumen 30 foracceptance of an axially movable blunt dissector 32. The blunt dissector32 is mounted within the handle 12 and extends through the support 20and the shaft 22. The blunt dissector 32 is preferably provided at itsproximal end with a relatively large diameter body portion 34 adaptedfor reciprocal motion within tubular handle 12. Body portion 34 ispreferably provided with a slightly smaller diameter recessed portion 36for receiving a return spring 38 which biases the blunt dissector 32 inthe proximal direction and has a lumen 40 extending therethrough whichis in fluid communication with the lumen 42 of the narrow portion of theblunt dissector. Alternatively, any of a variety of well known means canbe utilized to provide a proximal bias on the blunt dissector 32.

The length of body portion 34 is less than the axial length of thecavity within handle portion so that the body portion 34 has an axialrange of motion within the range of from about 2 mm to about 10 mm, andpreferably about 0.12 inch (3 mm). The proximal end wall 44 of thesupport 20 which extends into the handle 12 acts as one limiting stopfor distal travel of body portion 34. The distal surface of the end wall14 of the handle limits proximal travel of body portion 34. Spring 38pushes against an' annular shoulder 46 on body portion 34, biasing theblunt dissector 32 15 proximally.

The distal end of blunt dissector 32 is provided with a blunt dissectiontip 48 having a lumen therethrough. Spring 38 normally biases the bluntdissector 32 towards a first retracted position within the distal end ofshaft 22 such that the blunt dissection tip 48 does not extend from theshaft 22. Axial distal force on body portion 34 extends the bluntdissection tip 48 into a second position in which it extends from theshaft 22. Although the blunt dissection tip 48 may be extended andretracted in any number of ways, such as by use of a knob or button, itis preferred that a rotatable cam 50 be used.

The cam 50 is attached to a post 54 extending proximally from the handle12 and having a lumen 18 therein which is in fluid communication withthe lumen 40 in the recessed position of the blunt dissector and thelumen 42 in the narrow portion of the blunt dissector. The cam 50 isrotatably mounted about a pin 56 which extends along an axisperpendicular to the longitudinal axis of the shaft 22. The proximal endof the body portion has a rod 19 which extends proximally through anopening in the proximal end wall 14 of the handle.

The cam 50 has of least a two position engaging surface which, whenrotated into position, engages the rod 19 of the body portion. In afirst position, the cam 50 is biased by the return spring 38 to aposition in which the blunt dissection tip 48 is fully retracted withinthe shaft 22. In a second position, the bias imposed by return spring 38is overcome and engaging surface of the cam 50 engages the rod 19 suchthat the blunt dissection tip 48 is extended outwardly from the shaft22. The cam 50 is preferably provided with an actuator portion 58 whichextends radially outwardly and which may be used by the operator forrotating the cam.

Alternatively, other means such as pneumatic force generating means,hydraulic force generating means, piezoelectric force generating means,and electric force generating means may be used to overcome the bias ofthe spring and extend the blunt dissection tip 48.

It is preferred that this instrument be manufactured from a sterilizablematerial having sufficient rigidity for its intended purpose. Manyacceptable materials are well known in the art, such as stainless steelfor the shaft 22, and stainless steel or a plastic for the handleportion 12.

Alternatively, the guide member placement device may be made in adisposable form. In this embodiment, the components preferably are madeof a suitable thermoplastic. In particular, the thermoplastic Cycolac2679F made by General Electric Plastics has been found suitable, whichis Acrylonitrile Butadiene Styrene (ABS). Preferably, the shaft 22,blunt dissector 32, and return spring 38 are made of stainless steel.

The use of the guide member placement devices of FIGS. 1-7D in arepresentative bladder neck stabilization procedure employing a sling isdescribed below and depicted in FIGS. 8-14. However, those skilled inthe art will appreciate that the guide member placement device may alsobe used in a number of other surgical procedures requiring introductionof a guide member.

The following procedure is intended to place a guide member in thetissue between the urethra and the vaginal wall without puncturing thevaginal wall. A Foley catheter is placed in the bladder to identify thebladder neck. The guide member placement device is percutaneouslyinserted into the body. For example, a pair of approximately one inchsuprapubic incisions 60 and 61, shown schematically in FIG. 9, may bemade over the pubic tubercles and dissection may be carried down to thearea of the rectus fascia. A first guide member placement device 10 isplaced within one of the incisions and advanced along the back side ofthe pubic bone so that the distal tip of the shaft 22 is in contact withthe bone/fascial surface to decrease the risk of puncturing the bladder.As resistance is felt, the cam 50 is pressed to extend the bluntdissection tip 48 from the distal end of the shaft 22, thereby creatingan opening in the body tissue 62 as shown in FIGS. 8 and 11. The cam 50is then released, retracting the blunt dissection tip 48 into the shaft22, and the device 10 is advanced through the opening in the bodytissue. This process results in the creation of a first opening in thebody tissue.

The first guide member placement device 10 is advanced until it ispositioned under the urethra 64 within the tissue 62 lying between theurethra 64 and the upper vaginal wall 66 as shown in FIG. 9. The bluntdissection tip 48 is extended and retracted during advancement of theguide member placement device 10 so as to create an opening in thetissue. Advancement of the guide member placement 10 device withextension and retraction of the blunt dissection tip 48 is continueduntil the distal end of the shaft 22 is positioned approximately midlineto the urethra 64 as shown in FIG. 10 such that the distal end of theshaft 22 extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina.

Alternatively, a pocket or opening in the tissue between the urethra andthe vagina may be created beneath the bladder neck prior to insertion ofthe first guide member placement device using the devices and methodsdescribed below. In this embodiment, the first guide member placementdevice 10 is advanced such that the distal end of the shaft is in thepocket or opening and the device is positioned as described above.

As the guide member placement device 10 is advanced, the elastic uppervaginal wall tents. This tenting can be utilized to determine theposition of the guide member placement device 10. The guide memberplacement device is advanced until tenting is apparent at the desiredlocation.

The above process is repeated with a second guide member placementdevice 1910 as shown in FIG. 12. The second guide member placementdevice 1910 has an engaging member 1928 complementary to that of thefirst guide member placement device 10 as shown in FIG. 6. The bluntdissection tip 1948 of the second guide member placement device 1910 isextended and retracted to create a second opening in the body tissue asdescribed above and shown in FIG. 11.

The second guide member placement device 1910 is advanced to a positionapproximately midline to the urethra 64 such that the distal end of theshaft 1922 extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina.

Alternatively, in the embodiment in which the pocket or opening in thetissue between the urethra and the vagina is created prior to insertionof the first guide member placement device, the second guide memberplacement device is advanced into the pocket or opening.

The second guide member placement device 1910 is then aligned with thefirst guide member placement device 10.

The first and second guide member placement devices 10 and 1910 are thenjoined through their engaging members 28, 1928, creating a continuousopening in the tissue 62 between the urethra 64 and the upper vaginalwall 66, as shown in FIG. 13. In an alternative embodiment, in additionto joining the two shafts, the two handles may also be coupled togetherand secured to one another.

After joining of the two guide member placement devices 10, 1910, thelumens 42, 1942 of the blunt dissectors are in fluid communication withone another, as shown in FIG. 6. As shown in FIGS. 13 and 2, a guidemember 68 is then inserted into the lumen 18 in the handle 12 of thefirst guide member placement device 10 and advanced through the lumens40, 1940, 42, 1942 of the blunt dissectors of the first and second guidemember placement devices 10, 1910 until it exits from the handle 1912 ofthe second guide member placement device.

The engaging members 28, 1928 of the two guide member placement devices10, 1910 are then disengaged from one another and the devices 10, 1910are removed from the patient's body, leaving the guide member 68 inplace, as shown in FIG. 14.

The guide member 68 may then be used to introduce a sling attached to asling application catheter in order to stabilize the bladder neck orstabilize the urethral floor as described in the following sections.

In alternative embodiments of the method, rather than using the bluntdissection tips 48 of the guide member placement devices to create thecontinuous opening in the tissue, the guide member placement device maybe inserted to a pre-formed opening in the tissue between the urethraand the upper vaginal wall. The pre-formed opening may be created byhydrodissection or with balloon catheters as described below. The stepsof this embodiment of the method are similar or identical to the methoddescribed above. However, if desired, this embodiment of the method canbe practiced with guide member placement devices having a bluntdissector which is fixed in a position in which it is extended from theshaft.

In an alternative embodiment of the method, the guide member placementdevice may be advanced through a trocar into the tissue between theurethra and the upper vaginal wall. In another embodiment, the guidemember placement device may be viewed laparoscopically during theprocedure to ensure proper positioning and assist in the alignment ofthe first and second guide member placement devices.

Sling Application Catheter

Another aspect of the present invention is a sling application catheterfor introducing a sling into an opening or pocket in the patient's bodytissue. In particular, the sling application catheter of the presentinvention can be used in urethral floor reconstruction procedures, suchas bladder neck stabilization procedures, to introduce a sling into thetissue between the urethra and the upper vaginal wall in a less invasivemanner than the techniques currently in use.

Generally, the sling application catheter comprises a catheter having asling therein which is releasably engaged with the catheter. Preferably,the sling is releasably engaged by a pouch in the catheter. Preferably,the sling application catheter is adapted to be guided along a guidemember. The guide member may be a suture, guide wire, or other structuresuitable for guiding the sling application catheter to a desiredlocation.

The sling application catheter may be attached to the guide member,suture, or other guiding device in numerous ways. For example, thecatheter may have a lumen extending therethrough through which the guidemember passes. The guide member may pass along the full length of thelumen, thereby extending entirely through the catheter. Alternatively,the guide member may extend partially through the lumen but exit thecatheter along its length through an opening in the wall of thecatheter.

In yet another embodiment, a loop with an aperture therein may beattached to the catheter. In this embodiment, the guide member passesthrough the loop to guide the catheter along the length of the guidemember. Those skilled in the art will appreciate that there are avariety of other ways to permit the sling application catheter to travelalong the guide member, and the present invention contemplates suchadditional approaches.

Preferably, the sling application catheter is long enough to spanbetween an insertion site in the patient's body and an exit site in thepatient's body. The insertion site and exit site are positioned oneither side of the location to which the sling is to be delivered.

The catheter may be a continuous cylinder with a lumen extendingtherethrough. Alternatively, the surface of the catheter may bepartially open with a slot therein which is narrower than the width ofthe guide member, suture or other guiding device. Preferably, the distalend of the catheter has a tapered tip to facilitate its passage throughthe body tissue.

The pouch permits the sling to be handled without damage, maintains abarrier preventing microorganisms from contacting the sling, provideshandling flexibility, and ensures that the sling is introduced into theopening or pocket in the patient's body tissue in the desiredorientation. The pouch may be made of a variety of materials such aspolyethylene terephthalate (PET), polyethylene (PE), vinyl, polyesterand ethylene vinyl acetate (EVA). Preferably, the pouch is made of PET.

Preferably, the pouch is flat to facilitate delivery of the sling in aflat orientation. However, the pouch may also be conical, or rolledconical, and be provided with means for flattening the sling afterdelivery. Alternatively, the sling application catheter may be used inconjunction with slings made from materials which adopt a flatconfiguration after delivery.

Preferably, the pouch is clear or translucent to permit visualization ofthe sling within. In some embodiments, the pouch is made of a porousmaterial such as polyethylene, polyethylene terephthalate or vinyl. Inone embodiment, the pouch is adapted to receive a sling long enough topass between a first suprapubic incision on one side of the urethra anda second suprapubic incision on the opposite side of the urethra.

In an alternative embodiment, the pouch may be adapted to receive asling having a shorter length than the slings used with the embodimentdescribed above. Such slings are attached to the pubic bone by sutures.

Long and short slings suitable for use with the present invention aredescribed in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

The length of the pouch may be varied depending upon the length of thesling with which the sling application catheter is to be used.

One embodiment of a sling application catheter 210 according to thepresent invention is shown in FIGS. 15 and 16. The sling applicationcatheter of FIG. 15 comprises a catheter 212 and a pouch 214 adapted toreleasably engage a sling 216 attached thereto. The distal end 218 ofthe catheter is tapered and extends beyond the distal end 220 of thepouch. The distal end 220 of the pouch is also tapered to facilitate itspassage through the patient's body tissue. A lumen 222 extends throughthe catheter.

A cross section of the sling application catheter 210 of FIG. 15 with asling 216 inside the pouch 214 is shown in FIG. 17. The sling 216depicted in FIG. 15 is sufficiently long to pass between two suprapubicincisions on opposite sides of the urethra. Preferably, the sling 216extends beyond the proximal end 224 of the pouch of the slingapplication catheter to permit the proximal end 226 of the sling to begrasped or secured.

Alternatively, shorter slings which are attached to the pubic bone viasutures may be used. The sling 216 may have sutures or integralattachment members extending bilaterally therefrom. Long and shortslings suitable for use with the present invention are disclosed in U.S.patent application Ser. No. 09/023,398, entitled “Stabilization Slingfor Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A), filed Feb.13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28, 2000, andthe identically titled U.S. Provisional Patent Application Ser. No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference. In such an arrangement, a suture orintegral attachment member extends beyond the proximal end 224 of thepouch and can be grasped or secured by the physician to withdraw thesling from the pouch.

As illustrated in FIGS. 18 and 19, in alternative embodiments of thesling application catheter 310, the pouch 314 has a reinforcingstiffener 328. The reinforcing stiffener 328 may be on the interior orthe exterior of the pouch 314. The stiffener 328 provides rigidity andprevents distortion of the sling 316 during passage through thepatient's body tissue, as well as permitting the sling applicationcatheter 310 to dilate or tear an opening in the patient's body tissueas it passes therethrough. In this manner, the sling applicationcatheter 310 may be used to create an opening in the tissue between theurethra and the upper vaginal wall in which the sling is introduced. Thestiffener 328 may also provide a bending effect which permits the slingto follow an axial bend along its width. Finally, the stiffener 328reduces damage to the sling material during handling.

The stiffener 328 may be made of any of a variety of materialscompatible with the above described considerations such as polyethylene,polypropylene, or acrylic. Preferably, the stiffener 328 providesapproximately a 1 cm radius of bending.

In some embodiments, the stiffener 328 is made of a porous material suchas polyethylene or polyethylene terephthalate having pores which permita solution to access the sling during a soak as described below.

Preferably, the sling 216 introduced into the opening in the patient'sbody is sterile. In this regard, FIG. 20 depicts a further embodiment ofthe sling application catheter 410, in which the pouch 414 has pores 411to permit rehydration of slings made of natural materials and antibioticor saline soaks of the sling in the pouch prior to introduction of thesling into the patient. In this embodiment, the pouch 414 may be made ofa variety of materials, such as PE, PET or vinyl. Preferably, the porousmaterial has pore sizes ranging from about 100 microns to about 0.25inches. Preferably, the pouch 414 is made of vinyl having a pore size of0.125 inches.

The sling application catheters described above may be used in a varietyof procedures in which delivery of a sling to an opening or pocket inthe patient's body tissue is desired. A representative method in whichthe sling application catheter of FIGS. 15-20 are used to deliver asling in a bladder neck stabilization procedure is described below anddepicted in FIGS. 21-23. While the procedure is described withparticular reference to the sling application catheter 210 of FIG. 15,those skilled in the art will appreciate that the sling applicationcatheters 310, 410 of FIGS. 18 and 20 may also be used in the procedure.

A guide member 68 is introduced into the tissue between the urethra andthe upper vaginal wall using a device such as the guide member placementdevices 10, 1910 described above. As illustrated in FIG. 21, the guidemember extends between two suprapubic incisions 61 and 62 on oppositesides of the urethra 64. As shown in FIG. 21, the end of the guidemember 68 extending from the first suprapubic incision 60 in thepatient's body is inserted into the lumen 222 of the catheter 212 suchthat the guide member passes 68 entirely through the catheter 212. Asling 216 capable of passing beneath the urethra and through theabdominal tissue on opposite sides of the urethra 64 is inserted intothe pouch 214 such that the proximal end 226 of the sling extends fromthe proximal end 224 of the pouch.

Alternatively, a shorter sling 216 may be used. Such shorter slings maybe attached to the pubic bone by sutures. In this embodiment, the slingmay have sutures or integral attachment members extending bilaterallyand may be inserted into the pouch so that a suture or integralattachment member extends from the proximal end of the pouch.

Long and short slings suitable for use with the sling applicationcatheter are described in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

The physician percutaneously inserts the sling application catheter andadvances it along the guide member. For example, the sling applicationcatheter may be inserted through a first suprapubic incision 60. As thepouch 214 passes beneath the urethra 64, the physician grasps theportion of the sling or the suture or integral attachment memberextending from the proximal end of the pouch while continuing to advancethe sling application catheter 210, causing the sling 216 to bewithdrawn from the pouch 214 as illustrated in FIG. 22. The slingapplication catheter is advanced until it exits the patient's body at asecond suprapubic incision 61, leaving the sling extending between thefirst 60 and second 61 incisions as shown in FIG. 23.

Alternatively, when the shorter slings are used, the sutures or integralattachment members extend from the first and second incisions.

Following the completion of the preceding procedures, the sling 216 islocated in the tissue 62 between the urethra and the upper vaginal wall.

Following implantation, the sling or sutures or integral attachmentmembers extending therefrom may be sewn, stapled, riveted, or anchoredto any of a variety of structures, such as the pubic bone, Cooper'sligament or rectus fascia to stabilize or stabilize the bladder neck orto stabilize the pelvic floor. For example, the long sling may beattached directly to the pubic periosteum using staples, clips, orsutures or may be attached to the pubic bone with short sutures attachedto a bone anchor implanted in the pubic bone or fastened to the pubicbone with a headed nail or screw-like anchoring device.

The slings may be used to stabilize the bladder neck as described inU.S. patent application Ser. No. 09/023,398, entitled “StabilizationSling for Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A),filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28,2000, and the identically titled U.S. Provisional Patent ApplicationSer. No. 60/038,379, filed Feb. 13, 1997. The tension on the sling maybe adjusted as appropriate, using approaches such as those described inU.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosure of which is incorporated herein by reference, to support thebladder neck or stabilize the urethral floor, thereby maintaining orimproving urinary continence.

Tissue Dissector/Dilator

Another aspect of the present invention is a tissue dissector/dilator510 for creating an opening or pocket in a body tissue and dilating theopening or pocket with an expandable dilator. The tissuedissector/dilator finds particular application in urethral floorreconstruction procedures, such as bladder neck stabilization proceduresin which the tissue between the female urethra and the upper vaginalwall is dissected and dilated to facilitate placement of a therapeuticsling device designed to alleviate incontinence.

The tissue dissector/dilator can be used in percutaneous approaches inwhich the sling is introduced into an opening or pocket in the tissuebetween the urethra and the upper vaginal wall without entry of thevaginal canal. Such procedures are described in detail below.

The tissue dissector/dilator generally comprises a body with anon-compliant shaft attached thereto. Preferably, the shaft has at leastone lumen extending therethrough.

A dissector for creating an opening or pocket in the body tissue iscarried on the shaft. The dissector may be on the exterior of the shaftor in the interior. Preferably, the dissector is within the lumen of theshaft and is axially movable such that it is capable of being extendedfrom and retracted in the shaft to create an opening in the body tissue.

A dilator for dilating the opening or pocket is also carried on theshaft. The dilator may be on the exterior of the shaft or in theinterior. Preferably, the dilator is within the lumen of the shaft andis axially movable such that it is capable of being extended from andretracted in the shaft. Preferably, the dilator is expandable andcollapsible.

Preferably, the dissector and the dilator are integral. Alternatively,the movable dissector and the dilator can be separate elements of thetissue dissector/dilator. Preferably, both the dissector and the dilatorare axially movable.

In yet another embodiment, the dissector and the dilator are notintegral parts of the tissue dissector/dilator. In this embodiment, thedissector and the dilator are distinct devices which can be insertedinto the shaft of the tissue dissector/dilator at the point in thesurgical procedure in which tissue dissection or dilation is required.

A representative embodiment of the tissue dissector/dilator 510 is shownin FIG. 24. As shown in FIG. 24 the body 512 comprises a trigger 514, alocking wheel 516, and a spring return button 518. In the embodiment ofFIG. 24, the trigger 514 and the upper section 520 of the body each havea slot 522 and 524 therein which together define an aperture 526 adaptedto receive a syringe 528 therein. However, those skilled in the art willappreciate that the body 512 can have a number of configurationscompatible with the intended use of the- tissue dissector/dilator andthe present invention encompasses such additional configurations.

The spring return button 518 can slide along a slot in a vertical faceof the body. As shown in FIG. 24, the spring return button 518 is biasedtowards a first position at the proximal end of the slot by a spring. Asshown in FIG. 25, the spring return button 518 can slide to a secondposition in which it is locked in place. As illustrated in FIG. 25, inthe locked position, the spring return button 518 fits into a groove onthe body 512 and is located on a face of the body perpendicular to theface on which the spring return button 518 is located in the unlockedstate.

The spring return button 518 may have an internal extension inside thebody which has a proximal section adapted to receive a syringe tip.

As illustrated in FIG. 24, the shaft 530 is attached to the bottomportion 532 of the body 512 and has a lumen extending therethrough. Theshaft 530 may be fabricated from a number of non-compliant materialssturdy enough to resist torque applied while the device is advancedthrough the body tissue. Preferably the shaft 530 is made of stainlesssteel.

Preferably, the shaft 530 curves towards its distal end 534. Preferably,the curve is a small radius curve. Preferably, the distal end 534 of theshaft is at an angle of about 90° relative to the proximal portion ofthe shaft. However, those skilled in the art will appreciate that thecurve in the shaft 530 may vary depending on anatomical considerationsand the type of procedure in which the tissue dissector/dilator is to beused.

As shown in FIG. 25, a balloon catheter 536 is located within the lumenof the shaft 530 and is engaged by the spring return button 518. Asillustrated in FIG. 26, the balloon catheter 536 comprises an outer tube538 having a lumen extending therethrough and an expandable balloon 540in the lumen of the outer tube 538. An inflation tube 542 with a lumentherein is located at the proximal end 544 of the expandable balloon andis in fluid communication with the interior of the balloon 540.Preferably, the expandable balloon 540 has a blunt dissection tip 546 atits distal end 548.

The inflation tube 542 may be made of any of a number of materials, suchas PE or PET. Preferably, the inflation tube 542 is made of anon-compliant or minimally compliant material.

In the embodiment of FIG. 26, the expandable balloon 540 has acylindrical shape when expanded. Preferably, the dimensions of theballoon are adapted for dilating an opening or pocket in the tissuebetween the urethra and the upper vaginal wall. The length of theballoon is dependent upon the direction in which it is oriented relativeto the urethra in the procedure being used to create the pocket oropening. When the balloon is oriented perpendicular to the urethra theballoon is preferably 4-6 cm in length, with an effective width of 2 cmto create a pocket or opening of approximately 5 cm in length and 2 cmin width.

When used in procedures in which the balloon is oriented parallel to theurethra the balloon may be shorter than those used in procedures inwhich the balloon is perpendicular to the urethra. Balloons used in suchprocedures may also have a larger diameter than those used in proceduresin which the balloon is perpendicular to the urethra. Balloon cathetershaving a plurality of balloons side by side or flat profile balloons,such as those described in more detail below, are also well suited forsuch procedures.

Preferably, the balloon expands radially but does not increase in lengthwhen 30 expanded.

The blunt dissection tip 546 is preferably cylindrical in shape.Preferably, the blunt dissection tip 546 is about ¼ inch in length.

The blunt dissection tip 546 may be fabricated from a variety ofmaterials which are rigid enough to facilitate their use in bluntdissection of a body tissue. The tip of the balloon may be formed into asolid tip which functions as the blunt dissection tip. Alternatively,the blunt dissection tip 546 may comprise the same material as theinflation tube 542. In yet another embodiment, the blunt dissection tipmay be stainless steel.

The balloon catheter may also have a second lumen therein for receivinga guide member. In this embodiment, a guide member may be placed throughthe aperture in the body, pass through the shaft, and extend out of thedistal tip of the shaft, permitting the tissue dissector/dilator to beused to place a guide member in the opening or pocket created in thebody tissue. The guide member may be a suture, guide wire, or otherstructure suitable for guiding a sling to a desired location.

In another embodiment, the balloon catheter may have a third lumentherein for irrigation or for receiving diagnostics, such as anultrasound catheter. The third lumen may also be used for passage of animplant, such as fibrin glue or a bladder neck suspension orstabilization sling, such as those described in U.S. patent applicationSer. No. 09/023,398, entitled “Stabilization Sling for Use in MinimallyInvasive Pelvic Surgery” (VESITEC.023A), filed Feb. 13, 1998, now issuedU.S. Pat. No. 6,042,534, issued Mar. 28, 2000, and the identicallytitled U.S. Provisional Patent Application Ser. No. 60/038,379, filedFeb. 13, 1997, the disclosures of which are incorporated herein byreference.

As shown in FIG. 24, when the spring return button 518 is positioned atthe most proximal point of its path in the vertical face of the body512, the balloon catheter 536, including the blunt tip 546 and theexpandable balloon 540, is retracted within inside the shaft 530. Asillustrated in FIG. 27, when the spring return button 518 is movedtowards the distal end of the slot, force is communicated to the ballooncatheter 536 causing it to move axially towards the distal end 534 ofthe shaft, such that the blunt dissection tip 546 extends out of theshaft 530. If the spring return button 518 is then released, the biasfrom the spring will cause the spring return button 518 to return to themost proximal point of the slot, thereby returning the blunt dissectiontip 546 to a fully retracted position within the shaft 530. Preferably,the spring return button 518 provides a one to one stroke motion to theblunt dissection tip 546. When the spring return button 518 is locked atits most distal position, the expandable balloon 540 and the bluntdissection tip 546 protrude from the distal end 534 of the shaft, asshown in FIG. 25.

As shown in FIG. 24, the proximal end of the body is adapted to receivea syringe 528 therein. The syringe 528 comprises a plunger 550, areservoir, and a tip. The tip of the syringe engages the proximalsection of an internal extension of the spring return button 518. Asillustrated in FIG. 25, when the spring return button 518 is placed inthe locked position, the syringe 528 moves into the body 512 and ispositioned so as to permit the plunger 550 to engage the trigger 514.The tip of the syringe contacts the locking wheel 516 and engages a luerconnection thereon. When the locking wheel 516 is tightened, the syringe528 is firmly fixed in place such that the reservoir of the syringe isin fluid communication with the lumen of the balloon catheter.

With the spring return button 518 in the locked position, the plunger550 of the syringe engages the trigger 514, such that squeezing thetrigger 514 causes the plunger 550 of the syringe to be depressed. Whenthe reservoir of the syringe is filled with a fluid, such as sterilesaline or sterile water, squeezing the trigger 514 causes the fluid tobe dispensed from the syringe 528 into the lumen of the inflation tube542, thereby inflating the expandable balloon as illustrated in FIG. 28.The trigger 514 contains a return spring, such that when the trigger 514is released from the squeezed position, the trigger returns to itsoriginal position, drawing the plunger 550 of the syringe upward andthereby creating a vacuum in the syringe reservoir which draws the fluidfrom the expandable balloon 540 and deflates the balloon. The plunger550 and the trigger 514 may be interconnected through a variety ofstructures familiar to those skilled in the art. For example, they maybe interconnected through a rack and pinion gear.

An alternative embodiment of the tissue dissector/dilator 610 is shownin FIG. 29. In this device, the trigger 654 has an alternate shape asshown in FIG. 29 and engages a set of teeth 652 on the plunger 650 ofthe syringe. The body has a central aperture 626 therein which receivesthe syringe. Additionally, in this embodiment the locked position of thespring return button 618 is close to the bottom of the body 612 and thespring return button 618 is on the same face of the body in its lockedand unlocked states.

While several embodiments of the tissue dissector/dilator have beendescribed above, those skilled in the art will appreciate thatalternative configurations are compatible with the function of thedevice. Such additional configurations are within the scope of thisinvention.

The following section describes the use of the tissue dissector/dilatorin the context of a percutaneous bladder neck stabilization orsuspension procedure in which a sling is utilized for treating urinaryincontinence in females. However, those skilled in the art willrecognize that the tissue dissector/dilator may also find application ina variety of other procedures in which it is necessary to introduce anopening into a body tissue and subsequently dilate that opening. Whilethe procedure is described with particular reference to the tissuedissector/dilator 510 shown in FIGS. 24, 25, 27 and 28, those skilled inthe art will appreciate that the tissue dissector/dilator 610 shown inFIG. 29 may also be used in the procedure.

The shaft of the tissue dissector/dilator is inserted percutaneously.For example, percutaneous insertion may be through a one inch transverseincision made over a pubic tubercle with dissection is carried down tothe area of the rectus fascia. The tissue dissector/dilator 510, 610 isguided through the patient's body tissue along the back side of thepubic bone while maintaining the distal end of the shaft in contact withthe pubic bone. If resistance is encountered while advancing the tissuedissector/dilator through tissue, the spring return button 518 may berepetitively partially depressed and allowed to return to its mostproximal position through the action of the biasing spring. This processresults in repetitive extension of the blunt dissection tip 546 out ofthe shaft 530 and retraction of the blunt dissection tip 546 back intothe shaft 530, thereby dissecting an opening in the body tissue throughwhich the device is passing.

The tissue dissector/dilator 510 is advanced until tenting is observedon the upper vaginal wall. As shown in FIG. 30, the user thenmanipulates the distal end of the shaft 534 until it intersects thetissue 62 between the urethra 64 and the upper vaginal wall 66 atapproximately mid-thickness and in a direction which would permit theexpandable balloon to advance perpendicular to the axial direction ofthe urethra.

As illustrated in FIG. 31, the tissue 62 between the urethra 64 and theupper vaginal wall 66 is then blunt dissected by repetitively extendingand retracting the blunt dissection tip 546 using the spring returnbutton 518 as described above, thereby creating an opening in thetissue. The dissection process is repeated until an opening is createdin the tissue 62 which is large enough to permit the expandable balloon540 to be fully extended from the shaft 530 such that the distal end ofthe shaft extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina, as shown in FIG. 32.

The spring return button 518 is advanced to its locked position in whichthe expandable balloon 540 is fully extended into the opening in thebody tissue, as shown in FIG. 32. The syringe 528 is locked in placesuch that its reservoir is in fluid communication with the lumen of theinflation tube 542 of the balloon catheter 536 and its plunger 550engages the trigger 514. The trigger 514 is squeezed to dispense thesaline solution inside the reservoir of the syringe through theinflation tube 542 of the balloon catheter 536 and into the expandableballoon 540, causing the balloon 540 to expand. Expansion of the balloon540 dilates the body tissue, creating a first opening therein as shownin FIG. 33.

The trigger 514 is then released and is returned to its originalposition through the action of the return spring. As the trigger returnsto its original position, a vacuum is created in the reservoir of thesyringe 528, thereby drawing the fluid out of the expandable balloon 540and causing the balloon 540 to deflate.

The trigger 514 can be squeezed and released multiple times, ifnecessary, until the opening in the body tissue expands. The expandableballoon 540 and blunt dissection tip 546 are then retracted into theshaft 530.

The above dissection and expansion steps can be repeated while advancingthe tissue dissector/dilator through the tissue between the urethra andthe upper vaginal wall, as shown in FIGS. 34-36. The dissection andexpansion steps may be repeated until a continuous dilated opening orpocket 11 exists in the tissue 62, as shown in FIG. 37. Following thecreation of the continuous dilated opening or pocket, the tissuedissector/dilator is removed from the patient's body.

Alternatively, the continuous dilated opening or pocket 11 can becreated from both sides of the urethra. In this procedure, a firsttissue dissector/dilator is advanced approximately to the midline of theurethra while dissecting and expanding the tissue 62 as described aboveto create a first opening in the body tissue. The first tissuedissector/dilator may be removed from the body, or, in the embodimentsdescribed below in which two tissue dissector/dilators areinterconnected to pass a guide member or suture through the patient'sbody, the first tissue dissector/dilator may remain in the patient'sbody.

A second tissue dissector is percutaneously inserted. This may beaccomplished through a second suprapubic incision made on the oppositeside of the urethra from the first suprapubic incision. A second tissuedissector/dilator 510 is inserted into the second incision and advancedthrough the body tissue until it is aligned with the first opening inthe body tissue. Correct alignment of the second tissuedissector/dilator with the first opening in the body tissue isdetermined through visualization of tenting of the vaginal wall andthrough tactile sensation. The blunt dissector tip 546 of the secondtissue dissector/dilator 510 is extended and retracted from the shaft530, thereby creating a second opening in the body tissue which isjoined to the first opening in the body tissue. The expandable balloon540 is extended into the second opening and expanded within the secondopening, thereby dilating the body tissue. When the second tissuedissector/dilator 510 is removed from the patient's body a continuousdilated opening or pocket 11 exists in the tissue 62, as shown in FIG.37.

In both of the above methods, a sling may be introduced into the openingor pocket using the sling application devices described herein tosuspend or stabilize the pelvic floor.

In the embodiment in which the balloon catheter has a second lumen forreceiving a guide member, the tissue dissector/dilator may be used tointroduce a guide member as follows. After creation of the first openingor pocket but before removal of the first tissue dissector/dilator fromthe body, a guide member, suture, guide catheter, or webbing isintroduced into the second lumen of the catheter. When the first tissuedissector/dilator is removed from the body, the guide member is left inplace.

After creation of the continuous pocket but before removal of the secondtissue dissector/dilator from the body, the guide member in the firstpocket is introduced into the second lumen of the catheter of the secondtissue dissection/dilator and advanced therethrough. When the secondtissue dissector/dilator is removed from the body after creation of thecontinuous pocket, the guide member remains in place and extends betweenboth suprapubic incisions, passing under the urethra and through thecontinuous pocket. Alternatively, the tissue dissector/dilator may havean engaging member at the distal end of the shaft, permitting twodevices to be interconnected with their lumens in fluid communication asdescribed above for the guide member placement device. In thisembodiment, the guide member, suture, guide catheter, or webbing ispassed through the interconnected lumens of the first and second tissuedissector/dilators as described above in regard to the guide memberplacement device. Thus the guide member, suture, guide catheter orwebbing extends between the two suprapubic incisions and passes throughthe tissue between the urethra and the upper vaginal wall.

The guide member can then be used to introduce a sling into the openingor pocket as described above.

In yet another embodiment, the tissue dissector/dilator may be used intransvaginal procedures. For example, the tissue dissector/dilator maybe inserted through the upper vaginal wall rather than throughsuprapubic incisions. In this embodiment the device is advanced into thetissue 62 between the urethra and the upper vaginal wall and the balloonis expanded to create an opening or pocket as described above.

Sling Application Device and Sling Application System

Another aspect of the present invention is a sling application devicefor inserting a sling into an opening or pocket in a body tissue. Thesling application device provides access to the tissue between theurethra and the upper vaginal wall and introduces a sling into a pocketor opening in that tissue. In some embodiments, the sling applicationdevice creates the pocket or opening into which the sling is inserted.In other embodiments, the sling application device introduces the slinginto a pre-formed pocket or opening. The device may be used inpercutaneous methods alone or in laparoscopic procedures.

Another sling application device for introducing a sling into the tissuebetween the urethra and the upper vaginal wall is currently available.This device comprises two shafts, each having a central lumen, which canbe clamped together via horizontally extending tabs present at theproximal end of each shaft. Rotation of a lever on one of the horizontaltabs clamps the two tabs together, thereby locking the two shafts to oneanother.

The currently available device is used to introduce a sling into thetissue between the urethra and the upper vaginal wall as follows. Thetwo shafts are introduced into incisions on opposite sides of theurethra in the unlocked configuration. The shafts are advanced throughthe patient's tissue until they are located underneath the urethra withthe lumens of the two shafts aligned. The lever is then rotated to thelocked position, fixing the two shafts together. A sharp blade isinserted through the lumen of one of the two shafts such that itcontacts the tissue between the distal ends of the shafts. As the bladeis advanced through the tissue between the distal ends of the shafts,the tissue is dissected. Eventually, the blade enters the lumen of thesecond shaft, thereby creating a continuous opening in the tissuebetween the urethra and the upper vaginal wall.

The two shafts are unlocked and one of them is removed from thepatient's body. A suture is inserted into the eye of the blade and theblade is advanced into the opening in the tissue between the urethra andthe upper vaginal wall. A right angle clamp is then used to grasp andfollow the suture into the tissue between the urethra and the uppervaginal wall. When the jaws of the right angle clamp are spread, anenlarged opening sized to receive a sling is created. The sling is thenguided along the suture and introduced into the enlarged opening.

As will be apparent from the following description, the present slingapplication device provides several advantages over the currentlyavailable device. For example, the present device eliminates the use ofa right angle clamp to create the sling receiving opening which isrequired with the currently available device. Moreover, the slingintroducer permits the sling application device to introduce the slingwithout the use of a guiding suture as required with the currentlyavailable device. A further advantage of the present device and methodsfor using the device is that when the pocket or opening is created byhydrodissection the procedure can be performed without cutting thetissue between the two shafts of the sling application device.Furthermore, with the present device, it is not necessary to seat thedistal ends of the shaft together before locking the two halves of thedevice to one another.

The present sling application device generally comprises a first and asecond shaft. The first and second shafts have a central lumen which issized to allow a sling to advance therethrough. The lumens of the firstand second shafts may also be sized to allow a sling introducer to passtherethrough. Preferably, the shafts of the present sling applicationdevice are sufficiently wide to create or maintain an opening in thetissue capable of receiving the sling.

Preferably, the sling application device further comprises a firsthandle attached to the first shaft and a second handle attached to thesecond shaft. The first and second handles have openings therein whichare in fluid communication with the lumens in the shafts to which thehandles are attached. Preferably, the first and second handles areadapted to be connected to one another.

The present sling application device includes an adjuster forincrementally adjusting the distance between the distal ends of thefirst and second shafts. The adjuster allows the distance between thedistal ends of the shafts to be slowly decreased while monitoring thepatient to ensure that the urethra is not pinched during the procedure.This feature is absent from the currently available device, which hasonly two configurations, the locked and unlocked configurationsdescribed above. Preferably, the adjuster engages the first and secondhandles.

Preferably, the upper portions of the distal ends of the first andsecond shafts are indented relative to the lower portions of the distalends to reduce the possibility of pinching of the urethra during thesling implantation procedure. This feature is absent from the currentlyavailable device, increasing the risk of damage to the urethra when thatdevice is used.

The shafts of the present sling application devices are adapted toreceive several components during the sling application procedure suchthat the sling application device can be used as part of a slingintroduction system. The sling introduction system generally comprisesthe sling application device, a blunt dissector and a sling introducer.In some embodiments, the sling introduction system may further comprisea sharp tissue cutter.

A representative embodiment of the sling application device 710 is shownin FIG. 38A. As shown in FIG. 38A, the sling application device 710comprises a first handle 712 and a second handle 714, having first 716and second 718 shafts, respectively, attached thereto. The first andsecond handles have openings 725, 727 and therein which are adapted toreceive a sling or sling introducer. The first and second shafts 716,718 are adapted for insertion into a body tissue and have central lumens711 and 713, respectively, which extend therethrough. The lumens offirst and second shafts are in fluid communication with the openings inthe first and second handles and are adapted to receive a sling or slingintroducer. The first and second shafts 716, 718 have dimensions adaptedfor creating or maintaining a pocket or opening in the body tissue andfor receiving a sling introducer. The sling application device alsocomprises an adjuster 720 for adjusting the distance between the firstshaft 716 and the second shaft 718. Preferably, the adjuster 720 is anarticulating lock. As shown in FIG. 38A, the first handle 712 has agenerally rectangular distal portion 722, an indented region 724, and agenerally rectangular proximal portion 726 having a width less than thewidth of the generally rectangular distal portion 722. One face of thefirst handle 712 has a rectangular recess 728 open at each end forreceiving an extension 730 on the second handle.

As shown in FIG. 38B, the first handle has a locking button 732 with atab 717 thereon which is adapted to engage a groove 734 in the extension730 section which is disposed between the first handle 712 and thesecond handle 714, thereby locking the two handles together. Alignmentof the first handle 712 with the second handle 714 during locking isachieved by placing alignment pin 756 in alignment hole 758. However,those skilled in the art will appreciate that other means for aligningthe handles and locking them together may also be used.

A first shaft 716 with a central lumen therethrough extends through thefirst handle 712. As shown in FIGS. 39, 40 and 41, the first shaft 716is cylindrical and curves toward its distal end 736. The first shaft 716may be from about 3 inches to about 10 inches in length, with an outerdiameter from about 3/16 inch to about ⅝ inch with a wall thickness fromabout 0.010 inch to about 0.020 inch. Preferably, the first shaft 716 isfrom about 6 inches to about 8 inches in length, with an outer diameterfrom about 0.187 inch to about 0.275 inch. However, those skilled in theart will appreciate that the preceding dimensions may vary depending onahatornical considerations and the type of procedure being performed.

The first shaft 716 may be made of a variety of materials, includingstainless steel and aluminum. Preferably, the first shaft 716 is madefrom stainless steel.

The first shaft 716 is curved near its distal end. Preferably, the firstshaft 716 curves through an arc from about 80° to about 90°. Morepreferably, the first shaft 716 curves through an arc of about 90°.

In an alternate embodiment of the sling application device 810, shown inFIGS. 42, 43 and 44, the portion of the first shaft 816 proximal to thecurve is cylindrical and the portion of the first shaft 816 distal tothe curve is a flat tube. The flat tube may have a variety of crosssectional shapes such as rectangular, hexagonal or oval. The first shaft816 is curved as described above for the embodiment in which the shaftis cylindrical.

In a further embodiment of the sling application device 910, the firstshaft 916 comprises a tube which is flat along its entire length asshown in FIGS. 45 and 46. The first shaft 916 is curved towards itsdistal end as described above for the embodiment in which the shaft iscylindrical.

Preferably, the first shaft has a side bend. In accordance with thisembodiment, the first shaft can be flat, cylindrical, or flat in someportions and cylindrical in others as described above with respect tothe sling application devices 710, 810, 910 discussed above.

FIGS. 47, 47A and 47B show a sling application device 1010 in which theshafts have a side bend. In this embodiment, the first shaft 1016 isflat and has a first curved section 1021 and a second curved 1023section along its length. Preferably, the portion maximum offset betweenthe first curved section 1021 and the second curved section 1023 is fromabout 1 inch to about 3 inches. As shown in FIGS. 47 and 47B, the secondshaft 1018 has the same structure as the first shaft 1016. Preferably,the first and second shafts 1016, 1018 undergo a smooth transition fromcylindrical to elliptical or flat. More preferably, the portion of theshaft proximal to the first curved section 1021 is cylindrical and theportion of the shaft distal to the first curved section is flat.Preferably, the radius of curvature of the second curve is not planarwith the axial plane of the portion of the shaft. The adjuster 1020 inthis embodiment may be the same as the adjuster described above.

Alternatively, the shaft may have a 90° twist as shown in FIG. 48. Inthis embodiment of the sling application device 1910, the proximalportion 1929 of the first shaft 1916 is oriented at an angle of 90°relative to the distal portion 1931 of the first shaft, with atransitional section 1933 disposed between the proximal section of thefirst shaft 1929 and the distal section of the first shaft 1931. Theadjuster 1920 in this embodiment may be the same as the adjusterdescribed above.

Referring to FIG. 38A, one face 746 of the second handle is adapted toenable the physician to firmly grasp it when advancing the devicethrough tissue. An adjuster 720 is slidably mounted on face 746. Theadjuster 720 slidably engages a guide 748 on the bottom of the firsthandle 712. The guide 748 is hingedly connected to the extension 730 andis biased away from the extension 730 by a biasing means such as aspring 754 (indicated in FIG. 56) disposed between the guide 748 and theextension 730. Tabs 750 on the adjuster 720 fit into grooves 752 betweenthe sides of the extension 730 and the sides of the guide 748 such thatthe adjuster 720 moves along the guide 748 between a proximal end and adistal end. When the two handles have been locked together, moving theadjuster 720 along the guide 748 adjusts the distance between the distalends of the first and second shafts 716, 718 as depicted in FIGS. 56-58,which are discussed in greater detail below. However, those skilled inthe art will appreciate that there are other adjuster designs compatiblewith the operation of the present device, and such designs arespecifically contemplated in the present invention.

As the adjuster 720 is moved towards the distal extreme of the guide748, the resistance of the spring biasing the guide away from theextension 730 is overcome and the distance between the distal ends ofthe first and second shafts 716, 718 decreases. As the adjuster 720 ismoved towards the proximal extreme of the guide 748, the spring pushesthe guide 748 away from the extension 730 and the distance between thedistal ends of the first and second shafts 716, 718 increases.

The second handle 714 has a second shaft 718 extending therethrough. Thesecond shaft 718 may have the same configurations and be made of thesame materials as described above with regard to the first shaft 716.Preferably, the second shaft of the second handle has the sameconfiguration as the first shaft of the first handle with which it is tobe used, as illustrated in FIGS. 38-48.

Preferably, as shown in FIG. 49, the upper edges 738 and 740 of thedistal ends of the first and second shafts 736, 715 are slightlyindented relative to the lower edges 742 and 744 to reduce thepossibility of the urethra being pinched during the sling implantationprocedure.

A further aspect of the present invention is a blunt dissector fordissecting the body tissue without scoring or creasing the tissue orbone with which it comes in contact. The blunt dissector is adapted forinsertion into the first and second shafts of the sling applicationdevice and protrudes from the distal ends of the shafts. The bluntdissector can be used as a component in the sling application system.

The blunt dissector may be an obturator 1110 as shown in FIG. 50. Theobturator comprises an elongate, flat shaft 1112 interposed between aflexible section 1114 located at the distal end of the shaft and ahandle 1116 located at the proximal end of the shaft 1112. When theobturator 1110 is inserted into the first and second shafts 716 and 718of the sling application device, the flexible section 1114 bends topermit the obturator 1110 to conform to the curves near the distal endsof the shafts 716 and 718. The flexible section 1114 has a generallyrigid tip 1118 at its distal end which extends from the distal ends ofthe first and second shafts 716 and 718 when the obturator 1110 isinserted therein. The generally rigid tip 1118 prevents scoring of thetissue or bone with which it comes in contact when the first and secondshafts 716, 718 are advanced through tissue. In an alternate embodiment,the flexible section may have an opening near its distal end to increaseflexibility.

The shaft 1112 of the obturator may be made of a variety of materialssuch as polycarbonate, nylon, polypropylene, and Acrylonitrile ButadieneStyrene (ABS). A preferred material is ABS.

The flexible section 1114 of the obturator may be made of any of anumber of materials, including polycarbonate, nylon, polypropylene, andABS. Preferably, the flexible section 1114 is made of ABS.

The generally rigid tip 1118 of the obturator may be made of materialssuch as polycarbonate, nylon, polypropylene, and ABS. Preferably, thegenerally rigid tip 1118 is made of ABS.

When the obturator 1110 is inserted into the first and second shafts716, 718, the generally rigid tip of the obturator 1118 protrudes fromthe distal ends of the shafts 716, 718. Preferably, the generally rigidtip 1118 protrudes a distance of from about 0.1 inch to about 0.25 inchfrom the lower edges 742, 744 of the distal end of the shafts 716, 718.More preferably, the generally rigid tip 1118 protrudes a distance ofabout 0.20 inch from the lower edges 742, 744 of the distal end of theshafts 716, 718.

Yet another aspect of the present invention is a sling introducer 1210adapted for releasably engaging a sling 1211 and introducing the sling1211 into the body tissue without the use of sutures. The slingintroducer 1210 can be used as a component in the sling applicationsystem and is adapted for insertion into and advancement through thefirst and second shafts 716, 718 of the sling application device 710.Alternatively, the sling introducer can be used in conjunction withlaparoscopic trocars.

A representative sling introducer 1210 is shown in FIGS. 51 and 52. Thesling introducer 1210 can be made of any of a number of materials suchas polyethylene, PET or vinyl. Preferably, the sling introducer 1210 ismade of generally rigid vinyl.

The sling introducer 1210 of FIG. 51 has a narrow elongate distal tip1212 and a pouch 1214 at the proximal end. The elongate distal tip 1212of the sling introducer of the sling introducer is configured to passthrough the first and second shafts 716, 178 of the sling applicationdevice. The sling introducer 1210 is sufficiently long to permit thedistal tip 1216 of the sling introducer to protrude from the proximalend of the opening 725 in the first handle of the sling applicationdevice 710 while the sling 1211 protrudes from the proximal end of theopening 727 in the second handle of the sling application device 710.

The pouch 1214 of the sling introducer is sized to receive a sling 1211therein. The slings 1211 introduced with the sling introducer 1210 canbe long enough to extend between two suprapubic incisions or may beshorter slings designed to be attached to the pubic bone with sutures.Long and short slings suitable for use with the present invention aredisclosed in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

The pouch 1214 is relatively flexible, and is preferably made of a soft,pliable plastic such as polyethylene, PET or vinyl. In some embodiments,the pouch 1214 may be reinforced by a stiffener to provide some rigidityalong the edges as discussed above. The proximal end of the pouch 1214may be sufficiently wide to maintain the sling 1211 in a flatorientation. Alternatively, the pouch of the sling introducer 1210 maybe rolled up such that the sling is also in a rolled configuration.During introduction of the sling into the opening or pocket in the bodytissue, the sling 1211 may be converted to a flat configuration.

In one embodiment, the pouch 1214 has pores 1218 therein as shown inFIG. 51 to facilitate re-hydration or soaking treatments of the slingmaterials. In particular, the porous pouch 1214 permits solutions inwhich the pouch. is placed to contact the sling inside the pouch. Suchsolutions include saline solutions and antibiotic solutions. In thisway, the pores facilitate treatments in which the sling is soaked inantibiotics to prevent the growth of microorganisms on the surface ofthe sling after the sling 1211 is introduced into the body. The poresalso permit gas sterilization of the sling while it is inside the pouch.

In this embodiment, the pouch 1214 may be made of a variety ofmaterials, such as PE, PET, or vinyl. Preferably, the pouch is made ofclear material to permit visualization of the sling when it is insidethe pouch. Preferably, the pouch has pore sizes from about 0.10 inch toabout 0.25 inch. Preferably, the pouch 1214 is made of vinyl having apore size of about 0.125 inch.

In alternate embodiments, the pouch 1214 may be nonporous. Such pouchesmay be made of the same materials as described above for the porouspouches. However, the nonporous pouches do not have pores formedtherein.

Yet another aspect of the present invention is a tissue cutter 1310,1312 for cutting tissue disposed between the distal ends of the firstshaft and the second shaft. As shown in FIG. 53, the tissue cutter 1310comprises a razor 1312 housed in a razor assembly 1314. A flexiblecatheter 1316 extends from the distal portion of the razor assembly1314. A lumen 1318 extends through the catheter 1316. The width ofcatheter 1316 of the tissue cutter is slightly smaller than the width ofthe second shaft 718 of the sling application device 710, such that thecatheter 1316 can be inserted inside the second shaft 718. The tissuecutter 1310 can be used as a component of the sling application system.

In the tissue cutter shown in FIG. 53, the razor assembly 1314 comprisesa handle 1320 having a thumb button 1322 at its proximal end and anelongate catheter 1316 adapted to receive the razor 1312 therein. Thethumb button 1322 is movable between a proximal position and a distalposition and is biased towards the proximal position by a spring 1324inside the handle. When the thumb button 1322 is depressed, theresistance of the spring 1324 is overcome, and the thumb button 1322engages the razor 1312, moving the razor 1312 to a position in which itprotrudes from the distal end of the catheter 1316. When the thumbbutton 1322 is released, the razor retracts inside the catheter.

The razor 1312 is slightly smaller in width than the lumen of thecatheter 1316. The width of the razor 1312 is generally the same as thedesired width of the sling 1211 which will be inserted according to theprocedure described below. In addition, as shown in FIG. 53, the razor1312 is slightly tapered at its distal end.

Although several embodiments of the sling application device and thecomponents of the sling application system have been described above,those skilled in the art will appreciate that other configurations arecompatible with the operation of the device and the system. For example,a spring biased trigger on the first handle of the sling applicationdevice may substitute for the articulating lock for adjusting thedistance between the distal ends of the first and second shafts. Suchadditional configurations are also contemplated by the presentinvention.

The sling application device is used as follows. The method is performedwith the patient in the dorsal lithotomy position. In some methods apocket or opening 11 is created in the tissue between the urethra andthe upper vaginal wall using any of the methods and devices disclosedherein. In such methods, the first and second shafts 716 and 718maintain the opening or pocket in a configuration in which the sling canbe introduced.

Alternatively, the sling application device can be used to create theopening or pocket 11 in the tissue between the urethra and the uppervaginal wall.

Both the methods in which the sling application device maintains theopening or pocket and the methods in which the sling application devicecreates the opening or pocket are described below.

Each of the above described embodiments of the sling application devicecan be used according to the method described below and shown in FIGS.54-65.

After inserting an obturator 1110 into the lumen 711 of the first shaftsuch that the generally rigid tip 1118 extends from the distal end ofthe first shaft, the first shaft 716 is inserted percutaneously. Forexample, the first shaft 716 may be inserted into a first suprapubicincision 60, which is preferably approximately 1 to 1.5 inches inlength, and is located above a pubic tubercle. The first shaft 716 isadvanced into the patient's body and guided along the back side of thepubic bone to the upper vaginal wall. Once the vaginal wall is tented,placement is visually realized and lateral placement can then beadjusted. As shown in FIG. 54, the sling application device is thenrotated 90° such that the distal end of the first shaft 716 is directedperpendicular to the urethra 64 facing the tissue 62 between the urethra64 and the upper vaginal wall 66, creating and/or maintaining an openingor pocket in the tissue between the urethra and the upper vaginal wall.With the embodiments shown in FIGS. 47 and 48, the sling applicationdevice will rotate 90° as the device passes along the back of the pubicbone.

After inserting an obturator 1110 into the lumen 713 of the second shaftsuch that the generally rigid tip 1118 extends from the distal end ofthe second shaft 718, the second shaft 718 is inserted percutaneously.For example, the second shaft may be inserted into a second suprapubicincision 60, which is preferably approximately 1 to 1.5 inches inlength, and is located above a pubic tubercle. The second shaft 718 isadvanced into position as described above such that the distal end ofthe second shaft 718 is perpendicular to the urethra 64 facing thetissue 62 between the urethra 64 and the upper vaginal wall 66, therebycreating and/or maintaining an opening in the tissue between the urethraand the upper vaginal wall. As shown in FIG. 55, at the completion ofthis step, the distal ends of the first and second shafts 716, 718oppose each other in the tissue 62 between the urethra 64 and the uppervaginal wall 15 66.

After the sling application device is in position, the obturators 1110are removed from the first and second shafts 716, 718 and the first 712and second 714 handles are locked together with the adjuster 720 at itsmost proximal point, as shown in FIG. 56. The adjuster 720 is advancedtowards the distal extreme of the guide 748, progressively decreasingthe distance between the distal ends of the first and second shafts 716,718 as shown in FIGS. 57 and 58. During this process, the physician mayobserve the inner wall surface of the urethra 64 with a cystoscope toavoid pinching the urethra. The physician also observes the uppervaginal wall 66 to avoid pinching. When the first and second shafts 716,718 have been properly positioned, no pinching is observed at either theinner wall of the urethra or the upper vaginal wall. Correct placementis confirmed through touch and by visualizing a bulge in the uppervaginal wall at the desired positions.

Once correct placement has been obtained, the adjuster 720 is advancedto the distal extreme of the guide 748, compressing the tissue 62between the distal ends of the first and second shafts 716, 718, asshown in FIG. 58.

In the methods in which the sling application device 710 creates thepocket or opening in the tissue between the urethra and the uppervaginal wall, the tissue cutter 1310 is then inserted into the secondshaft 718 as shown in FIG. 59. When the thumb button 1322 of the razorassembly 1314 is depressed, the razor 1312 extends out of the distal endof the second shaft 718 and cuts the tissue 62 disposed between thedistal ends of the first and second shafts 716, 718, creating acontinuous opening 11 or pocket sized to receive the sling. The thumbbutton 1322 of the razor assembly 1314 is then released, causing therazor 1312 to retract within the second shaft 718. The razor assembly1314 is then removed from the second shaft 718.

In both the methods in which the sling application device maintains thepocket or opening and the methods in which the sling application devicecreates the pocket or opening, a sling or a sling introducer 1210 havinga releasably engaged sling 1211 attached thereto is inserted through theopening 727 of the second handle and into the lumen of the second shaft718, as shown in FIG. 60. The proximal end of the sling 1211 extendsbeyond the proximal end of the sling introducer 1210. Long and shortslings suitable for use with the present invention are disclosed in U.S.patent application Ser. No. 09/023,398, entitled “Stabilization Slingfor Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A), filed Feb.13, 1998, now issued U.S. Pat. No. 6,042,534, issued Mar. 28, 2000, andthe identically titled U.S. Provisional Patent Application Ser. No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

Preferably, a porous sling introducer 1210 is used and the porous slingintroducer 1210 with the sling 1211 attached thereto is soaked in awetting and/or antibiotic solution as described above prior to insertioninto the first shaft.

The elongate distal end 1212 of the sling introducer is advanced throughthe 2 opening 727 in the second handle, into the lumen of the secondshaft 718, into the lumen of first shaft 716, and out the opening 725 inthe first handle as shown in FIG. 61. While holding the proximal end ofthe sling 1211, the elongate distal end 1212 of the sling introducer1210 is pulled. The sling introducer 1210 is advanced until it exits theopening in the first handle 725, leaving the sling 1211 within the firstand second shafts 716, 718, as shown in FIG. 62. Following this step,the sling 1211 is located within the first 716 and second 718 shafts andextends out of the proximal ends of the openings 725,727 in the firstand second handles. As shown in FIG. 63, the end of the sling 1211extending out of the proximal end of the opening in the first handle isgrasped and the second shaft 718 is removed from the patient's body,leaving the sling 1212 in the opening 11 in the tissue which wasformerly occupied by the second shaft.

As shown in FIG. 64, the proximal end of the sling 1212 which hadformerly been inside the second shaft 718 is grasped, and the firstshaft 716 is removed from the patient's body. After this procedure, thesling 1211 passes through the continuous opening in the patient's bodytissue created by the above procedure, as shown in FIG. 65.

The sling 1212 may then be secured to a structure, such as the pubicbone by anchoring, stapling, riveting, or sewing to suspend or stabilizethe bladder neck or create a platform to stabilize the urethral floorusing approaches such as those disclosed in U.S. patent application Ser.No. 09/023,398, entitled “Stabilization Sling for Use in MinimallyInvasive Pelvic Surgery” (VESITEC.023A), filed Feb. 13, 1998, now issuedU.S. Pat. No. 6,042,534, issued Mar. 28, 2000, the identically titledU.S. Provisional Patent Application Ser. No. 60/038,379, filed Feb. 13,1997, and U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev etal., the disclosures of which are incorporated herein by reference.Tension on the sling may be adjusted using procedures such as thosedisclosed in the U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 toBenderev et al., the disclosure of which is incorporated herein byreference, to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

Detachable Member Sling Application Device and Retrieval Device

Another aspect of the present invention relates to a detachable membersling application device resembling the guide member placement devicediscussed above.

In general, the detachable member sling application device comprises ahousing with an introduction shaft having a lumen extending therethroughconnected to the housing. A detachable member is located on the distalend of the introduction shaft, the detachable member being connected toat least one of the sutures attached to the sling. The lumen in theshaft of the detachable member sling application device is capable ofreceiving a sling therein. Preferably, the sling is in an accordion likeconfiguration when inside the lumen. The accordion like configurationmay consist of random folds.

Optionally, the detachable member sling application device may furthercomprise an axially movable needle located inside the lumen of theintroduction shaft. The needle, which comprises a needle shaft and asharpened point, is extendable from the introduction shaft.

As illustrated in FIGS. 66-81, the shaft bends toward its distal end inthe same manner as discussed above with regard to the guide memberplacement device.

A detachable member sling application device 1410-according to thepresent invention is depicted in FIGS. 66-79. The detachable membersling application device comprises a housing 1412 and a shaft 1414 witha lumen 1416 extending therethrough. The shaft 1414 has an engagingmember 1411 near its distal tip for engaging a detachable member.Preferably, the engaging member 1411 comprises an annular ring on theouter surface of the shaft.

An axially movable inner shaft 1440 is located inside the shaft 1414 andis extendable therefrom and retractable therein. The axially movableinner shaft 1440 has a lumen extending therethrough. Movement of theaxially movable inner shaft 1440 is controlled by an actuator 1442 whichpivotally engages the housing 1412. Pivoting the actuator 1442 distallycauses the axially movable inner shaft to move distally.

An axially movable plunger 1444 is located inside the axially movableinner shaft 1440 and is extendable therefrom and retractable therein.Movement of the axially movable plunger 1444 is controlled by a button1446 which slidably engages the housing 1412. The button 1446 is movablebetween a first proximal position, a second intermediate position, and athird distal position. When the button 1446 is in first proximalposition, sharpened point 1425 of the axially movable needle 1422 isretracted in the detachable member.

An axially movable needle 1422 having a shaft 1423 and a sharpened point1425 at its distal end passes through an aperture in a deployment member1448 which is located inside a detachable member 1424 located at thedistal end of the shaft 1414. A spring 1413 is disposed between thedeployment member 1448 and the detachable member 1424. The engagingmember 1411 on the distal end of the shaft 1414 releasably engages thedetachable member 1424. Preferably, the detachable member comprises acup.

The detachable member 1424 has an engaging surface 1426 which engagesthe distal end of the shaft and a connecting member 1450. The connectingmember 1450 is connected to at least one suture 1428 attached to a sling1418 located in the lumen of the shaft 1414. Preferably, the sling 1418is in an accordion like configuration inside the shaft 1414 to reducethe amount of space it occupies.

When the button 1446 is in the intermediate position, -the sharpenedpoint 1425 of the axially movable needle 1422 is extended from thedetachable member 1424 so as to permit the tissue to be easily puncturedwhile the device is advanced. When the button 1446 is in the distalposition, the axially movable needle 1422 is maximally extended from thedetachable member 1424 such that the shaft 1423 protrudes from thedetachable member 1424 to permit extension through the hiatal area intothe vagina for ease of grasping and securing.

Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue. Oneembodiment of the retrieval device is illustrated in FIG. 67. Theretrieval device 2010 comprises a handle 2012 attached to a shaft 2014having an engaging member 2016 near its distal end.

The handle 2012 of the retrieval device may have a variety ofconfigurations which may vary depending on anatomical considerations andthe type of procedure being performed. For example, the handle may havea similar configuration as that of the detachable member slingapplication device shown in FIG. 66.

Similarly, the shaft 2014 of the retrieval device may have the sameconfiguration as the shaft 1414 of the detachable member slingapplication device 1410 shown in FIG. 66. Preferably, the engagingmember 2016 comprises an annular ring on the outer surface of the shaft2014.

In one embodiment, the retrieval device 2010 may be a modifieddetachable member sling application device 1410 having a hollow or solidshaft and lacking the actuator 1442, the button 1446, the detachablemember 1424, the sling 1418, and the mechanism inside the shaft fordeploying the detachable member.

The distal end of 2018 the shaft 2014 of the retrieval device has anengaging member 2016 adapted to engage the detachable member 1424.Preferably, the engaging member 2016 comprises an annular ring on theouter surface of the shaft. The shaft 2014 of the retrieval device maybe solid or may have a hollow interior.

Although the detachable member sling application device 1410 and theretrieval device 2010 described above and depicted in FIGS. 66 and 67may be used in a variety of procedures, a representative procedure forusing the device to apply a sling beneath the female urethra isdescribed below and depicted in FIGS. 68-81.

The first step of the procedure involves creating an opening or pocket11 in the tissue 62 between the urethra 64 and the upper vaginal wall 66into which the sling 1418 can be introduced. The opening or pocket 11may be created in a variety of ways, including those described hereinand in U.S. patent application Ser. No. 09/023,398, entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A) filed Feb. 13, 1998, now issued U.S. Pat. No. 6,042,534,issued Mar. 28, 2000, and the identically titled U.S. Provisional PatentApplication Ser. No. 60/038,379, filed Feb. 13, 1997, the disclosures ofwhich are incorporated herein by reference.

A preferred method of creating the pocket involves hydrodissection. Asshown in FIG. 68, a syringe 1430 filled with saline is inserted throughthe vaginal wall 66 into the tissue 62 between the urethra and the uppervaginal wall. A bolus of saline is dispensed into the tissue, creatingan opening or pocket 11 therein as shown in FIG. 68. Preferably, thebolus comprises about 4 cc of saline. The shaft 1414 of the detachablemember sling application device is inserted percutaneously. For example,the shaft 1414 may be inserted percutaneously through a first suprapubicincision 61. The shaft 1414 of the detachable member sling applicationdevice 1410 is inserted therein. The shaft 1414 of the detachable membersling application device 1410 is advanced through the patient's bodytissue along the back side of the pubic bone to the opening or pocket 11created in the tissue 62 between the urethra 64 and the upper vaginalwall 66, as shown in FIG. 69. During advancement of the shaft 1414, thebutton 1446 may be advanced from the most proximal position, in whichthe sharpened point 1425 of the needle is within the detachable member1424, to the intermediate position, in which the sharpened point 1425 ofthe needle extends from the detachable member. In particular, thesharpened point 1425 may be extended to dissect through muscle groups.

The distal end of the shaft 1414 is advanced percutaneously orlaparoscopically to the bottom of the pocket or opening 11 and thebutton 1446 is advanced to the most distal position, in which the needle1422 is maximally extended and the sharpened point 1425 passes throughthe upper vaginal wall 66 as shown in FIG. 70. The needle 1422 issecured on the vaginal side with a device such as a hemostat 1432 asshown in FIG. 71.

As shown in FIG. 72, the detachable member 1424 is then detached fromthe distal end of the shaft 1414 by pivoting the actuator 1442 distally,thereby causing the inner shaft 1440 to move distally such that itcontacts the deployment member 1448 and pushes the detachable member1424 off the distal end of the shaft 1414.

As illustrated in FIG. 73, the needle 1422 is toggled within the pocketor opening 11 such that the engaging surface 1426 of the detachablemember will be accessible to the engaging member 2016 of a retrievaldevice 2010. Preferably, the needle is toggled from about 30° to about150°. More preferably the needle is toggled from about 60° to about120°. In a highly preferred embodiment, the needle is toggled about 90°.

As will be appreciated by those skilled in the art, other methods ofpositioning the detachable member for engaging the engaging member of aretrieval device may be used with embodiments of the detachable membersling application device which do not have the axially movable needle.

The shaft 2014 of a retrieval device is advanced percutaneously orlaparoscopically into the opening or pocket 11 as shown in FIG. 74. Forexample, the shaft may be advanced into the opening or pocket through asecond suprapubic incision 60.

The distal end of the shaft 2014 of the retrieval device is insertedinto the detachable member 1424 and the engaging member 2016 engages theengaging surface 1426 of the detachable member 1424 as shown in FIG. 75.As shown in FIG. 76, the needle 1422 protruding through the vaginal wall66 is then pulled out of the deployment member 1448 and removed from thevagina so as not to draw bacteria back into the pelvic area.

As the shaft 2014 of the retrieval device is withdrawn from the pocketor opening 11, the connecting member 1450 on the detachable member 1424pulls the sutures 1428 connected to the sling 1418 out of the shaft 1414of the detachable member sling application device 1410, as illustratedin FIG. 77. As the shaft 2014 of the retrieval device is withdrawnfurther from the pocket or opening 11, the sling 1418 and the sutures1428 connected thereto are pulled out of the shaft 1414 of thedetachable member sling application device 1410, as illustrated in FIG.78.

The shaft 1414 of the detachable member sling application device 1410and the shaft 2014 of the retrieval device 2010 are withdrawn from thepatient's body as shown in FIG. 79. The sling 1418 is thereby left inthe opening or pocket 11 between the urethra 64 and the upper vaginalwall 66 such that the sutures 1428 extend from the first and secondsuprapubic incisions 60, 61 patient's body, as shown in FIG. 80.

Preferably, the sutures 1428 or integral attachment members attached tothe sling 1418 have markings 1436 thereon for ensuring that the sling1418 is properly centered beneath the urethra in the opening or pocket11. The markings 1436 on the sutures or integral attachment members areequidistant from the center 1438 of the sling. Following placement ofthe sling 1418 in the opening or pocket 11, the physician crosses thesutures 1428 as shown in FIG. 81. When the markings 1436 on the sutures1428 or integral attachment members are positioned along a lineextending transversely to the patient's abdomen, as shown in FIG. 81,the sling 1418 is properly centered in the pocket or opening 11.

The sling can then be attached to a bone anchor or other structures, andtensioned to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence, using approachessuch as those described in U.S. patent application Ser. No. 09/023,398,entitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed Feb. 13, 1998, now issued U.S. Pat. No.6,042,534, issued Mar. 28, 2000, the identically titled U.S. ProvisionalPatent Application Ser. No. 60/038,379, filed Feb. 13, 1997 and U.S.Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosures of which are incorporated herein by reference.

Tissue Expander Grasping Device, and Balloon Catheters

A further aspect of the invention relates to hiatal techniques forcreating an opening or pocket in the tissue between the urethra and theupper vaginal wall and devices for use in the hiatal techniques. Thehiatal methods can be practiced without the necessity for a vaginalincision, thus minimizing the risk of infection from the procedure.

As will be described in greater detail below, in the hiatal approach alumen is created in the hiatal tissue between the urethra and the uppervaginal wall. The lumen is then expanded to create an opening or pocketof a size sufficient to accept a sling. The opening or pocket is thenheld open with the tissue expander while a first suture or flexibleguide member is percutaneously advanced into the opening or pocket. Theguide member may be a suture, guide wire, or other structure suitablefor guiding a sling to a desired location. The first suture or flexibleguide member is grasped with a grasping device and withdrawn through thelumen and out of the body. The process is repeated with a second sutureor flexible guide member on the opposite side of the urethra. The twosutures or flexible guide members are then tied together to create aguide for delivering a sling into the pocket. The knotted section of thesuture or guide member is then translocated outside of the body so thatthe progress of the sling along the suture or guide member is unimpeded.

Alternatively, the sling may be attached to the sutures extendingoutside of the body, rolled or restuffed, and drawn into the bodythrough the lumen by pulling on the sutures.

As discussed above, after creation of the lumen in the hiatal tissue,the lumen is expanded to create a pocket or opening. One aspect of thepresent invention relates to balloon catheters for expanding the lumenand creating the pocket or opening. The balloon catheters generallycomprise an outer tube having a lumen extending therethrough and atleast one expandable balloon inside the outer tube. The expandableballoon has a blunt dissection tip at its distal end having sufficientrigidity to allow it to create an opening in a body tissue whencontacting the tissue.

One embodiment of a balloon catheter 536 suitable for use in the hiatalapproach was described above and is shown in FIG. 26.

In the embodiment shown in FIG. 26, there is a single expandable balloon540. In an alternative embodiment of the balloon catheter, there is morethan one balloon. This embodiment permits the creation of an opening orpocket wide enough to accommodate the sling using balloons having asmaller diameter than would a single balloon capable of creating apocket of that width. In this way, tearing of tissue above and below thepocket is minimized.

FIG. 82 shows a preferred embodiment 1536 in which there are twoexpandable balloons 1540 and 1541 in the lumen of the outer tube 1538which are joined at their distal ends. Preferably, the expandableballoons are joined at their distal ends by a blunt dissection tip 1546.The blunt dissector tip may comprise a plastic or metal cap.Alternatively, the ends of the two balloons may be potted together. Inthe embodiment of FIG. 82, the two balloons have a common inflationtube. However, those skilled in the art will appreciate that theballoons may also have separate inflation tubes.

FIG. 83 shows the embodiment of FIG. 82 in which the balloons 1540, 1541have been inflated. As illustrated in FIG. 83, the balloons 1540, 1541have a generally cylindrical configuration when inflated. In thisembodiment, each balloon 1540, 1541 may be from about 2 cm to about 3 cmin length and has a diameter when expanded of from about 1 cm to about2.5 cm. In a preferred embodiment, each balloon 1540, 1541 is from about2 cm to about 3 cm in length and has a diameter when expanded of fromabout 1.5 cm to about 2 cm. More preferably, each balloon is about 2.75cm in length and 2.5 cm in diameter when expanded.

Some physicians prefer procedures which take place beneath the pelvicfloor so as to avoid any unnecessary disruption of muscle, the slingsare preferably about 1.5 cm to about 6 cm in length and about 2 cm inwidth. More preferably, the slings used in such procedures are 2.5 cm to4 cm in length, although longer slings may be more manageable forgeneral surgeons since they allow for slippage off center during 30placement.

Other physicians prefer procedures which break through the pelvic floorand produce scarring which may reinforce the area. In such procedures,the slings may be as long as 20-25 cm. These long slings minimize thelength of attaching suture and permit more tissue ingrowth whileproviding security against suture breakage. Preferably, the slings usedin such procedures are about 2 cm wide.

Those skilled in the art will appreciate that the sling dimensions canbe varied as appropriate. In any case, however, it is preferred that theballoon on the balloon catheter is appropriately sized to create apocket or opening capable of accommodating the sling.

Alternatively, a balloon catheter 1636 having a flat profile balloon1640 may be used to create the lumen. The flat profile balloon 1640 iscapable of forming a flat pocket sized to receive a sling while avoidingthe unnecessary dilation or tearing of tissue above and below the slingpocket which may occur if a cylindrical balloon was used to create thepocket. Preferably, the flat profile balloon 1640 has a square orrectangular shape when inflated. However, those skilled in the art willappreciate that other shapes are compatible with the present inventionand that the shape may be readily modified to be compatible with theparticular device or procedure used.

The flat profile balloons 1640 are preferably made of two sheets ofnoncompliant material such as mylar, polyethylene, or PET.Alternatively, the balloons may be made by blow molding.

A flat profile balloon 1640 according to the present invention is shownin FIG. 84. As illustrated, the balloon 1640 has a series of internalnon-expansive ribs 1650 which serve to maintain a shallow profile afterexpansion, direct the flow of air to promote even unrolling duringexpansion, reduce buckling in critical areas after expansion, andprovide a conduit structure which delivers a consistent expansion oftissue into the desired shape. The internal structure of the catheterand balloon 1640 are further illustrated in the cross sectional views ofFIGS. 85 and 86.

As illustrated in FIG. 84, the balloon 1640 is located at the distal endof a generally rigid inflation tube 1642 which extends through theinterior of the balloon 1640. The inflation tube 1642 provides agenerally rigid support structure during advancement and placement ofthe balloon 1640 in the body tissue. Preferably, the inflation tube 1642has a series of fill holes 1658 in the interior of the balloon 1640which promote uniform inflation of the balloon. However, those skilledin the art will appreciate that a single fill hole may also be used.

In one embodiment, shown in FIG. 85, the inflation tube 1642 has twolumens in its interior. One lumen, the guide lumen 1652, is adapted toreceive a guide member, while the other lumen, the inflation lumen 1654,is for inflation of the balloon and is in fluid communication with theinterior of the balloon. In an alternative embodiment, the catheter hasa single inflation lumen.

Those skilled in the art will appreciate that the catheter may beprovided with more than two lumens to accommodate other instrumentsnecessary to perform the surgical procedure.

The inflation tube has a luer tip 1656 at its proximal end which isadapted to engage a syringe filled with saline or sterile water. Whenthe plunger of the syringe is depressed, fluid is force through theinflation lumen 1642 and out of the fill holes into the interior of theballoon, causing the balloon 1640 to inflate. When the plunger of thesyringe is retracted, a vacuum is created, drawing the fluid out of theballoon 1640 and causing the balloon to deflate 1640.

In a preferred embodiment, the balloon 1640 is rolled on the exteriorsurface of the inflation tube 1642 to reduce its entry profile.

Those skilled in the art will appreciate that the above describedballoon catheters 536, 1536, 1636 can be used to dilate body tissues incontexts other than the hiatal procedures discussed below. For example,the balloon catheters 536, 1536, 1636 may be utilized in the tissuedissector/dilator 510 described above, or may be used to create apre-formed opening for receiving the guide member placement devices 10,1910, the sling application devices 710, 810, 910, 1010, or thedetachable member sling application devices 1410 described above.

Additionally, the balloon catheters 536, 1536, 1636 of the presentinvention can also be used to create the opening or pocket in the tissuebetween the urethra and the upper vaginal wall in transvaginalincontinence treatments. In such transvaginal procedures the ballooncatheter is inserted through the upper vaginal wall into the area inwhich the opening or pocket is to be made. The balloon is then expanded,creating the opening or pocket for receiving a sling. In some instances,the physician may use the balloon catheters' in conjunction withtransvaginal bone anchor implantation devices such as those disclosed inthe copending U.S. patent application Ser. No. 08/744,439 entitled“Transvaginal Anchor Implantation Device,” filed Nov. 8, 1996, thedisclosure of which is incorporated herein by reference. However, use ofthe balloon catheters in conjunction with transvaginal bone anchorimplantation devices may impact the expense of such procedures.

The balloon catheters described above and depicted in FIGS. 2B and 82-86may be introduced into the body in a number of ways. In one method aneedle or guide member is inserted into the hiatal tissue to the desiredlocation. The needle or guide member is inserted into the guide lumen ofthe catheter. The catheter is advanced along the guide member or needleto the desired location. A syringe filled with saline or sterile wateris attached to the luer tip at the end of the catheter and the plungerof the syringe is depressed, ejecting the fluid from the syringe andcausing the balloon to inflate. The inflated balloon dilates or tearsthe tissue thereby creating a shallow opening or pocket adapted toreceive a sling.

In an alternate procedure, a hollow needle or trocar is introduced intothe body tissue and advanced to the desired location. A ballooncatheter, which may have a single inflation lumen, is passed through thelumen of the needle or trocar and advanced to the end. The needle ortrocar is partially withdrawn from the patient's body to expose theballoon. The balloon is inflated and deflated as described above tocreate an opening or pocket adapted to receive a sling.

Further aspects of the present invention relate to tissue expanders 1710for expanding an opening or pocket in a body tissue and grasping devices1810 for grasping a suture advanced into the opening or pocket.

In general, the tissue expander comprises a tube with a lumen extendingtherethrough, an expandable and collapsible member attached to the tubefor insertion into the opening within the body tissue and expansionthereof, and an expansion and collapse control in communication with theexpandable and collapsible member for moving the expandable andcollapsible member between a first position in which it is collapsed anda second position in which it is expanded.

One embodiment of a tissue expander 1710 according to the presentinvention is shown in FIG. 87. The tissue expander comprises a tube 1712with a lumen 1714 extending therethrough. Preferably, the lumen 1714 ofthe tube 1712 is of sufficient diameter to permit a visualizer, such asa fiberoptic scope, and a grasping device to be simultaneously housedtherein.

An expansion basket 1716 is attached to the tube 1712. Preferably, theexpansion basket 1716 comprises a plurality of wires 1718 joined attheir distal ends by a tip 1720 which is connected to a pull wire 1722.The expansion basket 1716 is movable between a first position in whichit is collapsed (indicated with solid lines) and a second position inwhich it is expanded (indicated with dashed lines) as shown in FIG. 87.When the pull wire 1722 is pulled towards the proximal end of thedevice, the expansion basket 1716 moves to the expanded position. Whenthe pull wire 1722 is released, the expansion basket 1716 collapses.

The expansion basket 1716 may be fabricated from a variety of materialssuch as stainless steel or Nitinol. Preferably, the expansion basket1716 is made of stainless steel.

The expansion basket 1716 may expand the tissue from about 0.25 inch toabout 1.5 inches. Preferably, the expansion basket 1716 expands thetissue from about 0.5 inch to about 1.25 inches. In a highly preferredembodiment, the expansion basket 1716 expands the tissue about one inch.

In an alternative embodiment of the tissue expander, a self-expandingnet or a self-expanding mesh tube may be used in place of the expansionbasket.

A further aspect of the present invention relates to a grasping devicewhich is adapted to fit inside the lumen of the tube of the tissueexpander described above. When inserted into the lumen of the tube ofthe tissue expander, the grasping device is axially movable andextendable from and retractable in the lumen of the tube. Generally, thegrasping member comprises a catheter with a grasper on its distal end.

A grasping device 1810 according to the present invention is shown inFIG. 88. The grasping device 1810 comprises an elongate member 1812 andself expanding grasping basket 1814 attached to the distal end of theelongate member 1812.

Preferably, the grasping device 1810 is adapted to fit inside the tube1712 of the tissue expander 1710. When the self-expanding graspingbasket 1814 is inside the lumen of the tube 1712 of the tissue expander1710, it is held in a collapsed configuration by the tube 1712. However,when the self-expanding grasping basket 1814 is extended outside thetube 1712, it expands. Preferably, in its expanded state, theself-expanding grasping basket 1814 on the grasping device 1810 fitsinside the expansion basket 1716 of the tissue expander 1710. When thegrasping device 1810 is retracted back into the lumen 1714 of the tube1712 it collapses.

The above grasping devices 1810 and tissue expanders 1710 can be used ina wide variety of surgical procedures in which it is necessary to expandan opening in a body tissue and grasp a suture which has been advancedinto the expanded opening. For illustrative purposes, the use of theabove devices in a hiatal bladder neck stabilization procedure isdescribed below.

FIG. 89 shows the urethra 64, the vagina 1836, the hiatal tissue 62between the urethra and the upper vaginal wall, and a target site 1816for insertion of a device for creating a lumen 1818 in the hiataltissue. In the hiatal bladder neck stabilization procedure disclosedherein, the urethra 64 is straightened prior to creation of the lumen1818 in the hiatal tissue.

As shown in FIG. 90, the urethra 64 can be straightened with a Foleycatheter 1820 inside a large bore tube 1822. The large bore tube 1822fits securely over the Foley catheter and extends out of the urethra.Preferably, the large bore tube is sufficiently firm to rigidify theFoley catheter.

Preferably, the large bore tube 1822 comprises a metal shaft. In apreferred embodiment the metal shaft includes a means to measure thelength of the urethra from the bladder neck to the proximal end. In someembodiments, the large bore tube 1822 has guide means thereon whichallow the needle 1830 or other dissecting device for dissecting thehiatal tissue, such as a cutter knife, to be guided to the desired site.Such devices are described in U.S. patent application Ser. No.09/023,533, entitled “Method and Apparatus for Minimally Invasive PelvicSurgery,” (VESITEC.028A) filed Feb. 13, 1998, now issued U.S. Pat. No.6,099,547, issued Aug. 4, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,380, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

As shown in FIG. 90, the Foley catheter 1820 is inserted into theurethra 64 and advanced to the bladder neck 1826. When the balloon 1828of the Foley catheter is inside the bladder neck 1826, it is inflated.Alternatively, the urethra 64 may be straightened with a urethroscope orby other methods familiar to those skilled in the art.

As shown in FIG. 91, a large bore needle 1830 is inserted into thehiatal tissue 62 between the urethra 64 and the upper vaginal wall 66 atthe target site 1816 indicated in FIG. 89. An appropriately sized needlemay be selected by measuring the distance between the balloon 1828 ofthe Foley catheter 1820, which is positioned at the bladder neck 1826,and the external urethra. The needle should be slightly shorter than themeasured length. For example, the needle may be approximately 0.25 inchless than the measured length.

The needle 1830 may be guided by eye or may be mechanically guided topenetrate the hiatal tissue parallel to the without penetrating theupper vaginal wall. The needle is advanced parallel to the urethra 64below the midline of the urethra.

As shown in FIG. 92, the needle 1830 is partially retracted and thelumen 1818 in the hiatal tissue 62 which was created by the needle 1830provides an access channel for the devices discussed above.

Alternatively, a bi-polar RF cutter may be used to dissect an opening inthe hiatal tissue. The bi-polar cutting device comprises a pair ofwires, one flexible and one rigid, for cutting a slot from the proximalportion of the hiatus to the bladder neck having a width adapted forreceiving a sling therein. Preferably, the bi-polar cutting devices uses80 Watts of power to cut and coagulate the tissue. In this embodiment,the large bore tube 1822 in which the Foley catheter is placed has aseries of thermistors and associated connectors which providetemperature feedback for use in conjunction with a bi-polar RF cutterdevice. Such devices are described in U.S. patent application Ser. No.09/023,533, entitled “Method and Apparatus for Minimally Invasive PelvicSurgery” (VESITEC.028A) filed Feb. 13, 1998, now issued U.S. Pat. No.6,099,547, issued Aug. 4, 2000, and the identically titled U.S.Provisional Patent Application Ser. No. 60/038,380, filed Feb. 13, 1997,the disclosures of which are incorporated herein by reference.

A balloon catheter 536 is inserted into the bore of the needle 1830 andadvanced beyond the tip of the needle 1830 into the lumen 1832 in thehiatus as shown in FIG. 93. Although FIG. 93 shows the balloon catheter536 depicted in FIG. 26 being used, the balloon catheters 1536 and 1636depicted in FIGS. 82-86 may also be used.

As shown in FIG. 94, the balloon 540 is then inflated with saline orsterile water, dilating the hiatal tissue 62 around the lumen 1818created by the large bore needle 1830. The balloon 540 is then deflatedand the balloon catheter 536 is withdrawn from the patient's body.

The tissue expander 1710 is inserted into the large bore of the needle1830 and advanced beyond the tip of the needle into the lumen 1818 inthe hiatal tissue 62, as shown in FIG. 95. The pull wire 1722 is thenpulled towards the proximal end of the tissue expander 1710, causing theexpansion basket 1716 to adopt the expanded configuration and therebyexpanding the lumen 1818 in the hiatal tissue as shown in FIG. 96.

A fiberoptic scope 1832 is inserted into the tube 1712 of the tissueexpander 1710 and is extended into the interior of the expansion basket1716.

A guide member placement device 10 such as that described above is usedto advance a suture 1834 or guide member from a suprapubic incision,along the back side of the pubic bone toward the upper vaginal wall. Thesuture 1834 or guide member is extended into the expansion basket 1716of the tissue expander 1710 as shown in FIG. 97. The fiber optic scope1832 permits the physician to visualize the position of the suture 1834or guide member in order to determine when the suture 1834 or guidemember is within the expansion basket 1716.

A grasping device 1810 is inserted into the lumen 1714 of the tube 1712of the tissue expander 1710. The self-expanding grasping basket 1814 ofthe grasping device is extended from the tube 1712, causing theself-expanding basket 1814 to expand, as shown in FIG. 97. The suture1834 or guide member 68 is positioned inside the self-expanding basket1814 and the self-expanding basket 1814 is pulled back into the lumen1714 of the tube 1712, causing the self-expanding basket 1834 tocollapse and grasp the suture 1834 or guide member, as shown in FIG. 98.As shown in FIG. 99, the self expanding basket 1814 is withdrawn throughthe tube 1712, drawing the suture toward the outside of the patient'sbody. The grasping device 1810 is removed from the tube 1712, pullingthe suture 1834 outside the patient's body.

A second suture is advanced along the back side of the pubic bone towardthe upper vaginal wall with a guide member placement device as describedabove. The second suture is positioned on the opposite side of theurethra from the first suture and is advanced into the expansion basket,grasped with the grasping basket, and drown outside the patient's bodyas described above. Following this procedure, a second suture or guidemember extends from the patient's body.

The large bore needle 1830 and tissue expander 1710 are then removedfrom the patient's body. The ends of the two sutures are knottedtogether and the ends of the knotted suture extending from thesuprapubic incisions are pulled to draw the knotted suture back into thebody. The knot is advanced out of one of the suprapubic incisionsproviding an uninterrupted suture or guide member extending between thesuprapubic incisions around the urethra. The suture provides a guidepath from the suprapubic incisions around the urethra which may be usedto introduce a sling using a sling introduction catheter as describedabove.

In an alternative embodiment, the large bore needle 1830 is left inplace. A sling is secured to the sutures outside the body, rolled orrestuffed, and then drawn through the bore of the needle and into theopening or pocket in the body tissue by pulling on the ends of thesutures extending from the suprapubic incisions.

The tension on the sling may be adjusted as described above. Boneanchors or other means may be used to secure the sutures as discussedabove to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

Although this invention has been described in terms of certain preferredembodiments, other embodiments which will be apparent to those ofordinary skill in the art in view of the disclosure herein are alsowithin the scope of this invention. Accordingly, the scope of theinvention is intended to be defined only by reference to the appendedclaims. In addition, for clarity, letter references are used in some ofthe claims. These letter references, however, are not meant to imply anyparticular order for performing the method steps.

Part B

The treatment of incontinence for intrinsic sphincter deficiency (ISD)can often be corrected surgically with the placement of a sling. Thissling may consist of a wide variety of well known biocompatiblematerials: bovine pericardium, autograft, synthetics, cadaveric tissue,collagen/synthetic blends and the like. The sling also may be placedthrough a variety of surgical procedures. Slings suitable for use inurethral or bladder neck stabilization or suspension procedures andmethods for implanting them are disclosed in U.S. Provisional PatentApplication 60/038,379, entitled “Stabilization Sling for Use inMinimally Invasive Pelvic Surgery” (VESITEC.023PR), filed Feb. 13, 1997,the disclosure of which is incorporated herein by reference. The extentof surgical intervention is a surgeon's preference, but all presentsurgical interventions require a vaginal incision. The presence ofmicroorganisms is high in the vagina; in procedures utilizing slings ofnon-autologous material, a high rate of infection has been reported. Theprocedure described herein approaches sling placement in a differentmanner from that requiring a vaginal incision. The vaginal hiatus isapproached just under the distal urethra and a cavity is dilated withinthe tissue parallel to the urethra and upper vaginal wall. This deviceand resultant pocket provide access for placement of the sling in thetreatment of ISD and urethral hypermobility. The dilator also may beused in an approach from within the vagina to create a pocket in thedesired location approaching the bladder neck.

Turning now to the drawings, FIG. 100 shows the urethra and the vagina4B with the vaginal wall 8B in between. The dotted line in FIG. 100represents an incision site in the vaginal hiatus 2B. The vaginal hiatus2B is the external tissue between the urethra and the vagina 4B, as wellas the tissue deep to that external tissue. The vaginal wall 8B isintended to refer to all interior surfaces of the vagina 4B.

The series of Figures from 101 a to 101 g demonstrates a sequence havingto do with one aspect of the present invention, referred to herein asthe dilator 10B. The dilator 10B consists of two distinct functionalunits, the insertion spreader 12B and the handle 18B. The insertionspreader 12B can have the appearance of a split tube, and each half ofthe insertion spreader 12B, or each half of the split tube, can be anelongated semi-cylindrical spreader guide 14B. The inventioncontemplates spreader guides 14B shaped other than semi-cylindrically,such as spreader guides 14B whose cross section when joined woulddescribe a square, a hexagon, and the like, depending on the applicationfor which it is used, and depending on the configuration of the card, tobe discussed below.

The spreader 12B has an open position in which the spreader guides 14Bare separated from each other, as in FIG. 101 d, as well as a closedposition in which the spreader guides 14B are closely aligned,substantially forming a cylinder, as in FIG. 101 c. The preferredseparation of the spreader guides 14B in the open position isapproximately 2.5 to 4 cm.

The spreader guides 14B are substantially parallel to each other whetherthe spreader 12B is in the open or closed position, or is moving fromone position to another. The spreader guides 14B have a distal end 15Band a proximal end 16B, the distal end 15B being for insertion into thetissue 9B, and the proximal end 16B being for attachment to the handles18B. In a preferred embodiment of this invention, the spreader guides14B are sharpened at the distal end 15B, to facilitate entry into atissue 9B and passage therethrough. The distal ends 15B of the spreaderguides 14B also may be shaped to cooperate with a needle 24B, which maybe inserted first into the tissue 9B (see FIG. 101 a) before insertionof the spreader guides 14B, to provide a path for the spreader guides14B to follow into the tissue 9B as they are inserted over the needle24B (FIG. 101 b).

The handles 18B of the dilator 10B have first 19B and second 21B ends.The first end 19B of each handle 18B is connected to the proximal end16B of each guide. The second end 21B of each handle 18B is adapted fora physician to grasp and manipulate the handles 18B. The handles 18B arejoined at a pivot 20B and may be moved about the pivot 20B relative toone another, in such a way that movement of the handles 18B translatesto displacement of the spreader guides 14B relative to one another. In apreferred embodiment of the invention, a ratcheting lock 22B is alsopart of the handles 18B, and provides a mechanism for the handles 18B tobe locked into a particular position, thus also locking the spreader 12Bin a particular position.

This aspect of the invention provides a method for creating a cavity ina tissue 9B. The needle 24B is optionally first inserted into the tissue9B as in FIG. 101 a. The spreader guides 14B of the spreader 12B areplaced in a closed position and are inserted into the tissue 9B over theneedle 24B (FIG. 101 b) or directly into the tissue 9B. The needle 24B,is used, is then withdrawn (FIG. 101 c). When the spreader guides 14Bare inserted to the desired depth, the handles 18B of the dilator 10Bare moved together, as shown in FIG. 101 d. This causes a separation ofthe spreader guides 14B until the dilator 10B is in the open position.The movement of the spreader guides 14B away from each other toward theopen position creates a cavity in the tissue 9B.

In a preferred embodiment of the method of this invention, the tissue 9Bis the vaginal hiatus 2B. In some cases, the practice of this method maybe facilitated with the additional step of performing an episiotomy onthe skin of the vaginal hiatus 2B. In an alternative embodiment, thismethod may be practiced on a tissue 9B of the vaginal wall 8B, forexample the upper vaginal wall, to create a cavity between the vagina 4Band the urethra. Also contemplated in this invention is the practice ofthis method in any tissue 9B wherein it may be advantageous tosimultaneously create a cavity and provide guide tracks for placement ofa medical device within the cavity.

An additional preferred embodiment of the method of the invention has asa first step the insertion of a needle 24B into the target tissue 9B,such as the vaginal hiatus 2B or vaginal wall 8B, as in FIG. 101 a. Theneedle 24B may be calibrated or otherwise marked to indicate the depthof its insertion, to allow a physician to accurately determine theproximity of the tip of the needle 24B to an internal structure, such asthe bladder neck 47B. In addition to a determination of the depth ofpenetration, the needle 24B may also provide a path for simplifiedinsertion of the spreader 12B of the invention.

Using an embodiment of the dilator 10B wherein the distal ends 15B ofthe guides 14B are adapted for cooperating with a needle 24B, thespreader 12B is moved to the open position, and the spreader 12Bspreader guides 14B are placed near the needle 24B, then the spreader12B is moved to the closed position. In the closed position the spreaderguides 14B, at least at their distal ends 15B, substantially conform tothe shape of the needle 24B and may follow its path into the tissue 9B,as in FIG. 101 b. The spreader guide 14B is then inserted to the desireddepth, at which point the needle 24B may be withdrawn, as in FIG. 101 c.Then, as before, the handles 18B are moved closer together, thus movingthe spreader guides 14B away from each other to the open position (FIG.101 d).

The ratcheting lock 22B portion of the handles 18B holds the handles 18Btogether and the spreader guides 14B apart. Movement of the spreaderguides 14B to the open position creates the cavity desired for insertionof a medical device, or for performing a desired surgical procedure.

As an alternative embodiment of this method, an additional step may bepreformed to facilitate creation of the cavity. In this embodiment, thetarget tissue 9B is fluid-dissected by injecting a solution into thetissue 9B prior to advancing the insertion spreader 12B into the tissue9B. This additional step of hydro-dissection may be preformed using avariety of physiologically suitable buffers or solutions. Thisadditional step provides an advantage in some cases, becausehydro-dissection may be tissue-selective with respect to the vaginalhiatus 2B and the urethra. That is, hydro-dissection may tend topreferentially dissect hiatal tissue without impinging upon urethral orbladder tissue. Accordingly, a first step of hydro-dissection thatcreates a saline bolus, may predissect the tissue without affecting theintegrity of the urethra. The subsequent step of passing the insertionspreader 12B into the tissue is therefore simplified, and the movementof the spreader guides 14B into the open position is also simplified,because a substantial portion of the cavity is already created by theprocess of hydro-dissection.

In one method of hydro-dissection and subsequent cavity opening with useof the dilator 10B, a needle is inserted into the upper vaginal wall 8Band the saline solution is delivered into the deep tissue of the vaginalhiatus 2B. The deep tissue of the vaginal hiatus 2B is thereby dissectedby the injected solution. Subsequent insertion of the spreader 12Bthrough the external skin of the vaginal hiatus 2B provides a route ofentry that is less susceptible of infection than may be the case where atissue cavity is created entirely transvaginally. Because the interiorof the vagina 4B harbors more microorganisms than the surface of thevaginal hiatus 2B, and is also much more difficult to surface sterilize,the exterior vaginal hiatus 2B may often be the preferred route of entryfor creating a tissue cavity for urethral and pelvic floorreconstruction. However, certain circumstances may dictate creation of atissue cavity transvaginally; the dilator 10B of the invention and themethods of its use are fully adaptable to creation of a cavitytransvaginally. Thus, the present invention provides a surgeon with aconvenient means of opening a tissue cavity and with alternative avenuesof entry to the tissue cavity. Additional devices and methods fortransvaginal urethral or pelvic floor reconstruction and urethral orbladder neck stabilization or suspension, suitable for use in connectionwith the present invention, are disclosed in U.S. patent applicationSer. No. 08/744,439 entitled “Transvaginal Anchor Implantation Device,”filed on Nov. 8, 1996, now issued U.S. Pat. No. 6,053,935, thedisclosure of which is incorporated herein by reference.

Another aspect of the present invention is a card 30B for advancing amedical device into a tissue cavity as shown in FIG. 101 e. The card 30Bhas lateral edges 32B, a distal portion 34B, and a proximal portion 38B.A part of the proximal portion 38B, the articulation opening 40B, may beadapted for articulation with additional devices that may be useful inpositioning or stabilizing the card 30B in certain methods of use. Thedistal portion 34B of the card 30B is adapted for carrying a medicaldevice into a tissue cavity. In one embodiment of the invention themedical device is a urethral sling 42B. The card 30B enables sling 42Bmanipulation without touching the sling 42B. This reduces contamination,and establishes the sling 42B position within the body and relative toother devices that may be used in positioning and securing the sling42B. The lateral edges 32B of the insert card 30B may be speciallyadapted to articulate with spreader guides 14B that provide a path intothe tissue cavity, such as the spreader guides 14B of dilator 10B. Thedistal portion 34B of the card 30B is inserted into the cavity byaligning it with the proximal ends 16B of the spreader guides 14B. Oncethe card 30B is thus aligned, the edges 32B of the card 30B easily slidealong the semi-cylindrical spreader guides 14B into the cavity untilreaching the proper depth in the cavity.

The card 30B and dilator 10B of the invention thus may be used in amethod for inserting a medical device into a tissue cavity. In apreferred embodiment of this invention, the medical device is a sling42B. Other medical devices that may be positioned with use of the card30B include pharmaceutical implants, therapeutic devices, closures,staples and clips. In the preferred method, a urethral sling 42B isplaced at the distal region of the insert card 30B. A cavity is formedin a target tissue 9B as described above. Briefly, the spreader 12B isplaced in a closed position and the spreader guides 14B are positionedagainst the surface of the target tissue 9B. The spreader 12B isinserted into the target tissue 9B and is then moved to the openposition by moving the handles 18B of the dilator 10B together. Thespreader 12B is held in the open position by the ratcheting lock 22B.With the sling 42B on the card 30B and the cavity opened, the card edges32B are aligned with the semi-cylindrical spreader guides 14B of thedilator 10B and the card 30B is inserted into the cavity until itreaches the desired depth. The card 30B is manipulated by its proximalportion 38B, and may be manipulated by means of an accessory toolcontacting the card 30B at the articulation opening 40B.

There are several advantages to this method of the invention. Oneadvantage is that the medical device can be placed without excessivecontact between the device and the patient. Excessive contact betweenthe surgeon and the device also may be avoided, which allows a reductionin handling and a reduced likelihood of contamination. This factminimizes the risk of infection in the placement of the device. Anotheradvantage is that the card 30B provides support for the device insubsequent steps of attaching the device in place inside the tissuecavity. A further advantage is that the spreader guides 14B providetracks along which the card 30B may enter, minimizing difficulties andvariability in the location of the sling 42B in the desired position.

This method is applicable to cavities made in the vaginal hiatus 2B aswell as in the vaginal wall 8B, specifically in the upper vaginal wall.Other uses for this method, involving the placement of a medical devicesupported on a card 30B with the assistance of the dilator 10B of theinvention, will be evident to those of skill in the art.

FIGS. 101 e, 101 f and 101 g show the steps of the method after thecavity is created. In FIG. 101 e the card 30B holding the sling 42B isaligned with the spreader guides 14B of the dilator 10B. In FIG. 101 fthe card 30B is inserted into the cavity by sliding the sides of thecard 30B along the semicircular tracks provided by the spreader guides14B of the dilator 10B. FIG. 101 g shows the card 30B in position in thetissue cavity after removal of the dilator 10B. As can been seen in FIG.101 g the proximal portion 38B of the card 30B and the articulationopening 40B remain outside the cavity for continuing or subsequentinteraction with accessory tools, such as those which are disclosedbelow in a discussion of other aspects of this invention.

The placement of the sling 42B or some other medical device by themethod of this aspect of the invention preferably precedes the securingof such a medical device inside the tissue cavity. The inventioncontemplates securing the sling 42B or other medical device in severaldifferent ways. In one embodiment the sling 42B may be placed in thecavity to be sutured therein by a suture 88B entering the cavity fromthe upper vaginal wall 8B. In another embodiment the sling 42B may bestapled or anchored into place subsequent to its positioning with theuse of the card 30B. Suturing of the sling 42B into position also may beaccomplished percutaneously, or with the suture being advanced fromabove or through the bone. Additional devices and methods forpercutaneous and hiatal approaches for urethral or pelvic floorreconstruction and urethral or bladder neck stabilization orstabilization, suitable for use in connection with the presentinvention, are disclosed in U.S. Provisional Patent Application No.60/03817, entitled “Percutaneous and Hiatal Devices and Methods for usein Minimally Invasive Pelvic Surgery” (VESITEC.029PR), filed Feb. 13,1997, the disclosure of which is incorporated herein by reference.

Preferred methods of securing the sling 42B in place may involveanchoring the sling 42B to a bone via a suture 88B and a bone anchor, ormay involve attaching the sling 42B to a suture 88B which passes througha bone, such as the pubic bone. This preferred embodiment of the methodof attaching the sling 42B into place after it has been delivered into atissue cavity by the card 30B of the invention will be discussed belowin connection with other aspects of the present invention. It will beevident to those of ordinary skill in that art that the method of thisaspect of the invention will be applicable to the positioning of severalkinds of medical devices. Such medical devices may be secured into placeafter their positioning by one of several known techniques.

Another aspect of the invention provides an incision guide 50B (see FIG.104) for cutting a cavity between the urethra and the vagina 4B, in thehiatal tissue. The incision guide 50B consists of a rigid catheter 52Band a cutter 54B, and may also consist of several other accessories toenhance or vary the performance of the incision guide 50B. The rigidcatheter 52B is a modified Foley-type catheter, preferably having ashaft of metal or other rigid material over the surface of the catheter.

The catheter 52B is inserted into the urethra and an integral bladderneck balloon 53B is inflated. (FIG. 102.) The rigid catheter 52Bstraightens the urethra and extends externally to provide a guide forattachment of devices which advance parallel to the urethra along thecentral hiatus plane. The balloon 53B holds the catheter 52B in place.Such devices which track along the rigid catheter 52B are used fordissecting the hiatus 2B laterally between the urethra and the uppervaginal wall 8B from the proximal urethra. A number of different methodsare contemplated.

The catheter 52B is therefore insertable into the urethra and is adaptedfor indicating the position of the bladder neck 47B. The rigid catheter52B functions to expand and straighten the urethra, providing a fixedreference point in the soft tissue of the urethral floor and hiatalplane. This fixed reference function also facilitates a surgeon'sdetermination of the lateral position of the urethra by palpation, orwith any of several forms of instrumentation.

The catheter 52B is designed to be of sufficient length to reach to thebladder 46B and also to extend outside the body of the patient. Thecatheter 52B will preferably have graduation marks or other indicia 58Bthereon to indicate the distance from the surface of the distal urethrato the bladder neck 47B and the bladder 46B. (FIG. 103.) The catheter52B, therefore, as it runs from the bladder neck 47B to the distalurethra and beyond, provides access for mounting and guidance of otherdevices, such as the cutter 54B. (FIG. 104.)

The cutter 54B is used for forming the desired cavity at a position thatis a fixed distance from, and therefore parallel to, the urethra. Thecutter 54B has a longitudinal axis of similar dimensions to the catheter52B, and has a cutting end 56B and a connecting end 57B. The cutter 54Bis adjustable at its connecting end 57B with the exterior portion of therigid catheter 52B and can slide along the catheter 52B, thus providingtracking guidance for the cutter 54B. (FIG. 104.)

The manner of attachment between the cutter 54B and catheter 52B willdetermine the amount of offset between the cavity and the urethra. Thepreferred distance of offset between the cutter 54B and the catheter 52Bis approximately 0.5 cm. This distance would in most patients positionthe cutter 54B to roughly bisect the distance between the upper vaginalwall 8B and the urethra. Because of the variability in the anatomy ofpatients, and the other ways in which this approach can be applied, apreferred range of offset may be from 0.25 cm to 0.75 cm. In otherembodiments a useful range may be from 0.1 cm to 0.9 cm. Again, becauseof the variability in patient anatomy, in some cases it may beadvantageous to further offset the cutter 54B from the catheter 52B by adistance of 1 cm or more.

The cutter 54B, being adapted to articulate with and slide along theaxis of the catheter 52B, provides a means for creating a cavity in thevaginal hiatus 2B. This cavity is in a predictable and optimally safeplane between the urethra and the upper vaginal wall 8B. The desireddimensions of the cavity may vary widely depending on the anatomy of thepatient and the purpose for which the cavity is made. In some cases, apreferred cutter 54B for attachment to the catheter 52B is a needle 62B.(FIG. 105 a.) In other cases a preferred cutter 54B is a blade 64B.(FIG. 105 b.)

A third preferred cutter 54B is a bipolar knife, providing lateraldissection of the vaginal hiatus 2B that is bloodless, by cutting andcoagulating the tissue simultaneously. With use of the bipolar knife, itis preferable to equip the metal portion of the catheter 52B withthermistors along its length, to measure the heat generated by thebipolar knife and provide temperature information to the surgeon. Oneembodiment of the bipolar knife, also known as the bipolar cutting loop,consists of a pair of wires, one flexible and one rigid, through which acurrent is passed to heat the loop.

Preferred dimensions of the cavity that is created may be from 1 to 3.5cm deep and may have a width ranging from the width of a needle 62B toapproximately 3.5 cm. The most preferred width for applications in whicha sling 42B is to be installed is approximately 2 to 4 cm. The preferreddepth of penetration of the cutter 54B is, of course, a function of theparticular anatomy of a given patient, and is to be determined by thesurgeon after insertion of the rigid catheter 52B and reference to theindicia 58B thereon.

Modified embodiments of the incision guide 50B include the attachment ofvarious other devices to further optimize the control that a surgeon mayexercise over the depth and direction of penetration of the cutter 54Bdevice. One such modification is to add one or more stops 60B to thedevice, as shown in FIG. 104. In one embodiment of this modification,one stop 60B is movably and lockably positioned on the catheter 52B.This stop 60B may have the form of a ring or a block, and may be lockedat a particular position of the catheter 52B by means of a thumb screwor a spring snap that articulates with the indicia 58B on the catheter52B at various positions along its length. The stop 60B slides onto theend of the end of the catheter 52B and may be locked in a certainposition on the catheter 52B to prevent advancement of the cutter 54Bpast the position of the stop 60B. The cutter 54B may also have a block61B intended to abut the stop 60B that is placed on the catheter 52B.Therefore the cutter 54B which slides along the catheter 52B may attachby means of a stop block 61B, or by other means of attachment that maysimilarly function as a stop block 61B.

This aspect of the invention provides a method for creating a cavity inthe vaginal hiatus 2B. The method begins with insertion into the urethraof the rigid catheter 52B. (FIG. 102.) The preferred catheter 52B is, asdiscussed above, provided with indicia 58B to indicate the position ofthe bladder neck 47B. The catheter 52B extends from the distal urethraof the patient, providing a linear guide for the cutter 54B. Accordingto the method, the position of the bladder neck 47B is determined. Nextthe cutter 54B is positioned on the catheter 52B and is advanced towardthe patient along the catheter 52B until the cutter 54B contacts andpenetrates the vaginal hiatus 2B. (FIG. 104.) The cutter 54B is theninserted into the vaginal hiatus 2B to a predetermined depth, thuscreating a cavity in the vaginal hiatus 2B that does not extend to thebladder neck 47B.

This method allows a surgeon to make an incision into the vaginal hiatus2B in a way that optimizes the safety, reproducibility, and reliabilityof the procedure. With a preferred embodiment of the incision guide 50Bas discussed above, the depth of insertion may be very preciselycontrolled, preventing damage to the bladder neck 47B. Likewise, thedisplacement between the urethra and cutter 54B is maintained constant,thus assuring that creating the cavity will not compromise the urethraor the vaginal wall 8B.

The various embodiments of the incision guide 50B also provide precisecontrol of the width of the incision. For example the incision width maybe that of a needle 62B (FIG. 105 a) of a selected gauge, or it may bethe width of a selected blade 64B (FIG. 105 b), or it may be the widthdetermined by the dimensions and orientation of the wires in a bipolarknife. An additional benefit of the method of the invention is that,because the cutter 54B tracks along the rigid catheter 52B, andtherefore tracks along the urethra itself, there is a constant lateralrelationship between the dimensions of the pocket and the position ofthe urethra. This assures that the cavity will have the dimensions,orientation, and position to optimize placement of a device within thecavity.

The depth of incision and the distance of offset between the urethra andthe cavity thus created is determined by the dimensions of theattachment block 61B between the cutter 54B and the rigid catheter 52B.(FIG. 104.) In a preferred embodiment of the invention, wherein therigid catheter 52B has attached thereto a stop 60B, the stop 60B may beprecisely positioned to prevent the advancing of the cutter 54B to adepth that would create a risk of damaging structures of the bladder46B.

Where the rigid catheter 52B is also equipped with thermistors,providing temperature feedback for safe use of the bipolar knife, anincision may be made rapidly and bloodlessly. Because of the potentialdamage caused by a bipolar knife in tissue close to critical structuressuch as the bladder 46B and urethra, many physicians would ordinarilyhesitate to make incisions with such an instrument. However, thisconcern is addressed through the use of the present method because theorientation of the cutter 54B and the catheter 52B provides very precisecontrol over the offset between the cutter 54B and the catheter 52B aswell as over the depth of penetration of the cutter 54B.

The incision guide 50B may be combined with the insert card 30B toprovide a method for inserting a medical device into a cavity. In thismethod a tissue cavity is created according to the steps of the methodprovided immediately above, and a card 30B supporting a medical deviceis inserted into the cavity. The medical device may be apharmacologically active implant, a prosthetic balloon, or a therapeuticdevice. In a preferred embodiment of this method, the medical device isa urethral sling 42B, as in FIG. 101 e. After the cavity is created withuse of the incision guide 50B, the card 30B may be inserted directlyinto the cavity, depending on the dimensions of the card 30B and thecavity. The medical device may be secured within the cavity by a varietyof means, after which the card 30B may be withdrawn. Alternatively thecard 30B may be withdrawn before the device is secured.

An additional embodiment of the method of the invention combines use ofthe dilator 10B of the invention together with the incision guide 50Band the card 30B. A cavity is created with use of the incision guide50B, as explained above, and then the cavity is stabilized and furtherdefined by insertion of the spreader 12B, which is then moved to theopen position, as in FIG. 101 d. With the spreader 12B in the openposition, the cavity may be stretched, if necessary. The cavity is alsoprovided with tracks along which the card 30B may easily slide to enterthe cavity, as in FIGS. 101 e and 101 f. Thus, the inventioncontemplates the use of the devices of the invention alone or incombination, in order to achieve the desired result.

With reference to FIGS. 106, 107, 108 and 109 in another aspect, thepresent invention provides a driver 70B for driving a bone-piercingguide 84B through the pubic bone. Originally, passing a suture 88Bthrough the pubic bone was done by drilling a hole through the generallyanterior portion of the pubic bone using a drill guide attached to astabilizer and vaginal retractor device.

A suture 88B was then passed through the drilled hole with a suturepasser. The present invention does not require the use of a drill and iscapable of creating small passages through the pubic bone, sufficient toallow passage of a suture 88B through the bone. The pubic bone isparticularly well suited for this adaptation because it is relativelyeasily pierced, due to its low density.

The driver 70B of the invention may be described as having four basicparts: a first jaw 72B, a slide bar 80B, a second jaw 82B, and abone-piercing guide 84B. (FIG. 106.) The first jaw 72B has a distal end74B and a proximal end 78B. The distal end 74B is adapted for insertinginto a tissue cavity and the proximal end 78B of the first jaw 72B isattached to the slide bar 80B. The slide bar 80B connects the first orfixed jaw 72B with the second or moveable jaw 82B. The second jaw 82Bslides along the slide bar 80B, with a releasable ratcheting action,toward the first jaw 72B. The bone-piercing guide 84B attaches to thesecond jaw 82B, and advances toward the first jaw 72B as the second jaw82B is ratcheted along the slide bar 80B.

A stop 86B on the slide bar 80B prevents further closing of the jawsonce the sharp end 96B of the cannula 90B exits the bone and is evenwith the first jaw 72B. The first jaw 72B has a slot 76B so that thesharp end 96B of the cannula 90B does not actually contact it whenexiting the bone. (FIG. 107.) The driver 70B may be equipped with adouble cannula jaw 82B (not shown) so that parallel passages may becreated through the bone simultaneously.

It is the function of the first or fixed jaw 72B inside a tissue cavityto provide a counterpressure on the bone opposite the pressure appliedby the bone-piercing guide 84B. Accordingly, the distal end 74B of thefirst jaw 72B may have a shape adapted to provide positions that canappress the inferior region of the pubic bone 45B lateral to the pubicsymphysis without crushing the urethra 6B. Such a configuration of thedistal end 74B of the first jaw 72B is shown in cross section in FIGS.123 a and b, 125 a and b, and 126 a; a detail view of a portion of theedge of the distal end 74B of the first jaw 72B is shown in FIG. 124. Inthese figures, the distal end 74B comprises a tongue 114B with a centraldepression 136B and elevated edges 138B. The edges 138B may have contactpins 140B adapted for piercing the tissue lying between the pubic bone45B and the elevated edge 138B of the tongue 114B. At the elevated edge138B there also may be a gap 144B through which a guide 84B may passwithout contacting the tongue 114B. Any device with opposing jaws havingone jaw adapted for insertion into a tissue cavity may preferably have atongue configuration as described above. The choice of a desirableconfiguration of the distal end 74B of the first jaw 72B may bedetermined by one of ordinary skill in the art, taking into accountanatomical considerations, the particular procedure involved, and thelike.

The pubic bone is an especially important structure for piercing insurgical applications. This is true for at least two reasons: the firstis that there are soft tissue structures in the proximity of the pubicbone whose dimension or displacement can result in several medicalproblems. The second reason is that the pubic bone is a relatively lowdensity bone and therefore may be pierced without the application ofundue force, if the force is properly oriented. The fact that the pubicbone may be pierced creates the possibility of stabilizing a soft tissuestructure near the pubic bone by attaching a device or a suture to thesoft tissue structure and stabilizing it by attachment to the relativelyimmovable pubic bone. In addition, by piercing through the bone, thesuture locking and tissue securing method may be accomplished from thesuperior/anterior bone surface, which is much more accessible than theposterior/inferior surface. The prior need to work near or at theposterior/inferior surface of the pubic bone arose from the proximity ofthis surface to the structures most often sought to be stabilized. Withthe methods and devices of the present invention, however, passage ofsuture through the pubic bone combines the desired proximity tostructures beneath the bone, with the convenience and simplicity ofintroducing and securing suture through the upper surface of the bone.Therefore the bone driver 70B of the present invention provides a deviceof potentially wide applicability for stabilizing structures of thepelvis, particularly in reconstruction and stabilization of the urethraland pelvic floor.

Alternative approaches to stabilizing structures of the urethral andpelvic floor or other soft structures of the pelvis by attachment to afixed reference tissue have relied on drilling a hole into the surfaceof a bone and placing into the hole a bone anchor to which a suture isattached. The difference between such approaches and the presentapproach is that the present invention allows a much smaller opening tobe made. This opening traverses the bone rather than being simply on thesurface of the bone. Through this much smaller passage may be passed asuture, without the need of a bone anchor. As used herein, a bone anchoris a device that attaches a suture to the surface of a bone, wherein thesuture thus attached does not pass through the bone. The presentinvention provides devices for connecting sutures to the bone, whereinthe sutures have passed through the bone. This is the basis for thedistinction, made in this specification, between “bone suture fasteners”and “bone anchors.”

A preferred embodiment of the driver 70B of the present inventionprovides a first jaw 72B, whose distal end 74B is adapted for insertioninto the vagina 4B. (FIG. 107.) An alternative embodiment provides a jaw72B whose distal end 74B is adapted for insertion into a cavity createdin the vaginal hiatus 2B as discussed above. A further embodiment mayprovide a first jaw 72B whose distal end 74B is adapted for insertioninto a transvaginally created cavity in the hiatal plane.

As alternative embodiments to the preferred ratcheting motion of thesecond jaw 82B toward the first jaw 72B, the jaws also may be broughttogether by various other mechanical advancing means, such as a threadedbar, in combination with a thumb screw. The bone-piercing guide 84B maybe hollow or solid; examples of bone-piercing guides 84B may be aneedle, a cannula, or a solid rod. The guide 84B also may be a cannulawith a removable obturator, so that the guide 84B behaves essentially asa solid rod while piercing the bone, but then can be converted to ahollow configuration for passing various devices along the lumenthereof. A preferred cannula size is believed to be approximately 14gage. In a preferred embodiment the guide 84B is sharpened andrelatively stiff, thus minimizing the possibility that the guide 84Bwill bend or skim along the surface of the bone, and increasing thetendency of the guide 84B to pierce directly into the bone along astraight line between the first jaw 72B and the second jaw 82B.

An advantage of the bone-piercing guide driver 70B is that the devicedoes not require that a hole be drilled through the bone. The passageremains open and completely accessible until the cannula 90B is removed,whereas the drilled hole is often lost once the drill bit is removed.Also, the drill requires additional incisions on both sides of the pubicbone to expose the bone, otherwise tissue is twisted around the drill asit turns.

The driver 70B of this aspect of the invention may be used by itself orin combination with devices of other aspects of the invention.Accordingly, the driver 70B may be used in connection with the dilator10B, for example, by creating a tissue cavity with the dilator 10B andthen placing the first jaw 72B of the driver 70B in the tissue cavitycreated by the dilator 10B. Likewise a tissue cavity may be created bythe incision guide 50B and the first jaw 72B of the driver 70B may beplaced inside the cavity thus created. Furthermore, the insert card 30B,capable of introducing into a cavity a medical device, also may be usedin connection with the driver 70B of the invention. In this particularcombination the first jaw 72B of the driver 70B may be configured tosupport the card 30B or connect with the articulation opening 40B of thecard 30B such that introduction of the first jaw 72B into the tissuecavity places the device in the appropriate position within the cavity.Subsequent operation of the driver 70B directly positions thebone-piercing guide 84B in the proper orientation with respect to thedevice supported on the card 30B. Therefore, use of the driver 70B incombination with devices of other aspects of the present invention mayresult in several beneficial methods for surgery on the urethral floorand other structures of the pelvis.

This method creates a path through the pubic bone, which path is usefulfor passing sutures 88B or medical devices through the pubic bone. Thereare several alternative embodiments of this method. In one embodimentthe guide 84B is passed through the bone to create a path through thebone and then the guide 84B is removed, leaving the path in the bone andin the tissue. After removal of the guide 84B, medical devices such as asuture 88B, a suture passer, or a suture securing device 126B may bepassed along the path through the bone that was created by thebone-piercing guide 84B. Any device capable of passing a suture throughtissue may be used in accordance with the present invention, includingthe suture passers and methods of their use, disclosed in U.S. patentapplication Ser. No. 08/042,739, filed Apr. 5, 1993, entitled “BladderNeck Suspension Procedure,” now issued U.S. Pat. No. 5,611,515, thedisclosure of which is incorporated herein by reference.

The driver 70B of the invention also may be used in a differentorientation such that the movable jaw is adapted for insertion into atissue cavity and for driving a device into the pubic bone from theposterior-inferior surface. As an example of a preferred embodiment, asling 42B with pre-attached push-in bone anchors (not shown) ispositioned on an insert card 30B and is placed into a tissue cavity withthe assistance of the dilator 10B or the incision guide 50B of theinvention, or by using both in combination. Next, the push-in anchorsare oriented to face and contact the pubic bone. Finally, the movablejaw of the driver 70B is placed below the push-in anchors of the sling42B and the fixed jaw of the driver 70B is placed against the patient'sabdominal surface such that the pubic bone lies between the fixed jawand the movable jaw. The movable jaw is then advanced toward the fixedjaw such that the push-in bone anchors are driven into theposterior-inferior surface of the pubic bone and the sling 42B issecured in place.

Other means of securing a sling 42B in place by using push-in type boneanchors are also contemplated in the invention. For example, a pivotingor otherwise manipulable tongue or insert card 30B that supports andpositions the sling 42B may be forcefully angled against the pubic bonesufficient to drive into the pubic bone the push-in type anchors fromthe posterior-inferior surface of the bone. In another embodiment,cannulas 90B are driven through the bone, both left and right of themidline, such that a path into the pubic bone is provided for initialguidance of push-in anchors. As the cannulas 90B on either side of themidline are withdrawn from the pubic bone, the push-in anchors (notshown) are pressed upward against the bone and initially follow the pathof the cannulas 90B. Thus, a guide hole is created by the cannulas 90Bfor the anchors. The application of additional upward pressure seats theanchors and the sling 42B is secured in place.

A preferred embodiment of the invention uses a cannula 90B as thebone-piercing guide 84B. (FIG. 108 a.) The lumen of the cannula 90Bconstitutes a path through the tissue and through the pubic bone.Accordingly, the path through the lumen of the cannula 90B allowspassage of sutures 88B or other devices through the bone without thedifficulty of locating the path through the bone. (FIG. 108 b.) In thismethod a cannula 90B (FIG. 108 a) is attached to the driver 70B, asshown in FIG. 107, and the first jaw 72B of the driver 70B is placedinside the tissue cavity, the pubic bone is located and the driver 70Bis positioned to align the pubic bone between the first jaw 72B and thesecond jaw 82B. The second jaw 82B is then advanced toward the first jaw72B, pushing the cannula 90B through the pubic bone and through the softtissue on either side of the pubic bone. Subsequently, a suture 88B ispassed through the cannula 90B and into the cavity.

Depending on the internal diameter of the cannula 90B, other devicesalso may be passed inside the lumen. For example, devices such as asuture passer, a quick connect device, and the like, may be passedthrough a cannula 90B of sufficient internal diameter. In a preferredembodiment, the cannula 90B has a sharpened tip 96B, and has arelatively high degree of stiffness.

This aspect of the invention provides a method of pelvic surgery thatuses the driver 70B of the invention wherein the guide 84B of the driver70B is a cannula 90B. The first jaw 72B of the driver 70B is insertedinto the tissue cavity, and the pubic bone is located. The driver 70B ispositioned to align the pubic bone between the first jaw 72B of thedriver 70B and the second jaw 82B of the driver 70B. The second jaw 82Bis advanced toward the first jaw 72B, forcing the cannula 90B into thetissue and through the pubic bone. After the cannula 90B passes throughthe pubic bone it is further advanced along the same line into thecavity, approaching the first jaw 72B of the driver 70B. Alternatively,a first cannula 90B can be used to pierce the pubic bone, and a secondcannula 90B may be passed within the lumen of the first cannula 90B toits final position on either side of the urethra. A suture 88B is thenpassed into the lumen of the cannula 90B and is advanced through thecannula 90B until it enters the tissue cavity. The end of the suture 88Bthat is in the tissue cavity is secured there and the second end of thesuture 88B is secured to the pubic bone. The attachment thus createdbetween the pubic bone and the tissue cavity stabilizes the tissuecavity and structures nearby. (FIG. 109 b.)

There exist several alternative embodiments of the method of this aspectof the invention. In one embodiment, the cannula 90B is removed afterthe first end of the suture 88B passes through the cannula 90B and intothe cavity. The cannula 90B is therefore withdrawn, leaving both ends ofthe suture 88B on opposite sides of the pubic bone prior to theattachment of either end of the suture 88B in its place. In anotherembodiment of this method, the suture 88B is attached within the cavityand then the cannula 90B is withdrawn, followed by the attachment of thesecond end of the suture 88B to the bone.

The mode of and purpose for attachment of the suture 88B within thecavity is variable, and the factors affecting the selection of the modewill be appreciated by one of ordinary skill in the art. For example,the suture 88B may be affixed in the cavity with one or more stitches92B (FIG. 109 a) to tissue therein. Alternatively, the suture 88B may beattached to a device for distribution of pressure across relativelywidened area of tissue, such as suture button 94B or a sling 42B. (FIG.108 b.) The suture 88B also may be attached to a staple (not shown)within the cavity, such that the staple anchors the suture 88B, so thatappropriate tension on the suture 88B elevates the tissue to which thestaple is attached.

Without the use of an additional device, attaching the suture 88B totissue within the cavity may make possible amelioration of certainincontinence conditions that arise from hypermobility of the urethra orfrom intrinsic sphincter deficiency. This is done simply by attachingthe suture 88B to tissue and then providing an appropriate tension. Thistends to elevate the tissue, which therefore elevates the urethra atthat position a distance A (compare FIGS. 109 a to 109 b), eliminatingor easing the condition causing urinary incontinence.

An alternative embodiment of this aspect of the invention uses thedriver 70B to insert a cannula 90B into the tissue cavity by passing itthrough the pubic bone as described above. In this embodiment, however,the end of the suture 88B which is advanced through the cannula 90B andinto the tissue cavity is passed through a structure 93B within thetissue cavity. It is subsequently passed back out of the cavity andsecured to the pubic bone, along with the second end of the suture 88B.In this embodiment of the invention, the structure 93B through which thesuture 88B may be passed include a suture button 94B or grid, a sling42B, and a tissue mass adjacent the cavity (creating stitches 92). Thecannula 90B advantageously has a sharpened end 96B and a reinforcedstiffness, to facilitate its passage in a straight line through the boneand to minimize skimming along the surface of the bone. Further, forembodiments of this method, the cavity is preferably a cavity in thevaginal hiatus 2B created according to one of the other methods of thisinvention. The cavity also may be the vagina 4B, or a cavity in thehiatal tissue created transvaginally.

This method is advantageous particularly for the stitching of a tissuemass for stabilization of the urethra floor or other pelvic structures.(FIG. 109.) Because the suture 88B enters and then again exits thetissue cavity, it may be passed through several stitching 92B points inthe tissue before it is withdrawn through the cannula 90B and out to thepubic bone. Both ends of the suture 88B may be secured to the pubic bonein a variety of ways, many of which will be explained in detail below.

This method may be advantageously practiced with the additionalassistance of a suture passer device. The suture passer is advancedthrough the cannula 90B and into the tissue cavity upon completion ofthe desired number of sutured stitches 92B within the cavity, the suture88B is grasped by the suture passer, and withdrawn through the cannula90B to properly position it at the surface of the pubic bone forattachment. This method may be preferably used for tensioning,stabilization, or elevation of a tissue mass adjacent to the urethra oradjacent to another soft tissue structure in the pelvis that may be inneed of stabilization or reorientation. The fact that the suture 88B issecured to the bone creates a stability for the target tissue mass thatis desirable in many cases. It also may be desirable to use this methodin securing in a tissue cavity a pharmacological implant, a prostheticdevice, or a therapeutic device.

This aspect of the invention provides an additional method for pelvicsurgery wherein the driver 70B is used to pass a guide 84B through thepubic bone along a first path, proceeding into the tissue cavity at afirst position. A suture 88B is then passed through the cannula 90B intothe cavity. The driver 70B is then used to create a second path throughthe pubic bone, arriving at a second location within the tissue cavity.The suture 88B which was passed along the first path through the pubicbone and into the cavity may then be passed along the second path out ofthe cavity and through the pubic bone at the second position. Both endsof the suture 88B may then be secured to the pubic bone. In this method,the suture 88B that passes through the cavity may preferably also bepassed through a tissue mass of the cavity, a suture button 94B or agrid, or a sling 42B, prior to exiting the cavity along the second paththrough the pubic bone. Alternatively, by simply passing the suture 88Bthrough the cavity and then tensioning it properly, the suture 88B mayserve to elevate the tissue mass and stabilize the structures adjacentthereto.

The invention thus provides several alternatives for stabilizingstructures of the urethral floor or other structures of the pelvis bysecuring the soft tissues to the pubic bone. The methods differprimarily in the paths along which the suture 88B is advanced. However,whether one chooses to advance the suture 88B into the cavity and anchorone end of the suture 88B therein, or to advance the suture 88B into thecavity and return it out of the cavity along one path, or to advance thesuture 88B into a cavity along a first path and retract it from thecavity along a second path, all three methods may be adapted to severalvariations. In all of these methods, the tissue cavity may be the vagina4B. It also may be a cavity in the hiatal tissue created, for example,either by the dilator 10B or by the incision guide 50B of the presentinvention as previously described. Alternatively, the cavity may be acavity created transvaginally by opening a pocket in the hiatal tissuethrough the upper vaginal wall 8B.

Furthermore, in any of the methods of this aspect of the invention, apreferred embodiment would perform the method on both the right and leftside of the midline of the patient, to equally distribute points ofattachment on either side of the urethra. Likewise, another preferredembodiment of any of these three methods would involve the additionalstep of tensioning the suture 88B prior to its attachment to the pubicbone. Suture tensioning may be accomplished in a variety of ways, one ofwhich is with the use of suture tensioning device. This type of devicehas a handle with which the surgeon can place the device next to thelocation where the suture 88B will be tied. Attached to the handle isanother structure of the suture tensioner around which the suture 88Bwill be wrapped, and upon which the suture 88B may be tied. The externaldimensions of this structure control the degree of slack that the suture88B retains after the suture 88B is tied. Therefore, based on the lineardistance between the bone and the soft tissue sought to be stabilized,as well as the amount of slack needed to achieve a particular objectivefor a given patient, a suture tensioner with an appropriate diameterwill be selected so as to provide the proper amount of tension in theconnection between the bone and the soft tissue.

The several methods of passing a suture 88B through one or more paths inthe pubic bone may be particularly applied to a method for stabilizing aurethral sling 42B relative to the pubic bone. In this method a cavityis created in the vaginal hiatus 2B. The cavity may preferably be madeusing the dilator 10B or the incision guide 50B of the presentinvention, or both in combination. The dimensions of the cavity and theamount of offset from the urethra will be determined according to thesize of the sling 42B that is needed, the dimensions of the patient'surethra, and the surgeon's preference. After the cavity is formed, guide84B is driven through the pubic bone to create a path. This is done byplacing the distal end 74B of the first jaw 72B of the driver 70B intothe tissue cavity followed by positioning the second jaw 82B of thedriver 70B, such that the pubic bone lies in a straight line between thefirst jaw 72B and second jaw 82B. A urethral sling 42B is placed intothe cavity either before or after the cannula 90B is driven through thepubic bone and into the cavity. The sling 42B may be placed into thecavity with the aid of an insert card 30B as discussed above, or byother surgical procedures known in the art. With the cannula 90B in thecavity adjacent the sling 42B, the suture 88B is attached to the sling42B and to the pubic bone.

This method is embodied in a technique wherein the cannula 90B iswithdrawn before the suture 88B is secured on either end. The methodalso contemplates withdrawal of the cannula 90B after the sling 42B issecured but before the suture 88B is secured to the bone. In addition toattaching the sling 42B with sutures 88B, this method contemplates anindirect attachment of the sling 42B to sutures 88B by directlyattaching the sling 42B to devices which are themselves attached tosutures 88B. An example of such an indirect attachment to a suture 88Bis a securing device 126B as disclosed herein. This method mayadvantageously involve use of the devices of other aspects of thepresent invention. The tissue cavity may be made either by the dilator10B or the incision guide 50B, or by using both together, and the sling42B may be delivered to its proper position in the cavity with aid ofthe insert card 30B as discussed above. Depending on the particularmanner in which the insert card 30B articulates with a driver 70B, thecooperative use of the insert card 30B may precisely position the sling42B. This will cause the bone-piercing guide 84B to meet the sling 42Bat the appropriate straight line position as is desirable in thismethod.

Another aspect of this invention provides a driver frame assembly 100B.The driver frame assembly 100B serves to align, support and stabilizeboth the patient's pelvis and the devices of the invention in proceduresfor reconstructing the urethral and pelvic floor or for performing othermethods of pelvic surgery. The driver frame assembly 100B has an upperclamp 102B, a rigid catheter 52B, a cavity tongue 114B, a lower clamp120B, and at least one driver 70B. The upper clamp 102B of the driverframe assembly 100B has a head portion 104B, a descending arm 106B and abase portion 108B. The head portion 104B has a compression foot 110Bthat is used to compress a patient's abdominal surface against the pubicbone. The compression foot 110B has stabilizing pins 112B that extenddownward therefrom and that pierce the patient's skin 48B, penetratingthe abdomen at a position adjacent to the superior surface of the pubicbone. The compression foot 110B may be pressed against the abdomen ofthe patient with, for example, a threaded screwing mechanism, aratcheting or piston mechanism, or a linkage mechanism. The stabilizingpins 112B are designed to be of a length that makes it impossible forthe pins 112B to cause damage to any abdominal or pelvic organs. At thesame time the stabilizing pins 112B have dimensions making themsufficiently strong to resist the lateral forces exerted with operationof the driver 70B.

The rigid catheter 52B portion of the driver frame assembly 100Bfunctions much as the rigid catheter 52B of the incision guide 50B, asdiscussed above. The catheter 52B is intended to straighten and elongatethe urethra, as well as to assist in identifying the position of theurethra, the bladder 46B; and bladder neck 47B. The rigid catheter 52Bis of sufficient length to extend outward beyond the distal urethra ofthe patient. This external extension of the rigid catheter 52B providesa structure with which the frame assembly may articulate and attach.(FIG. 110.)

The tongue 114B portion of the driver frame assembly 100B is adapted forinsertion into a tissue cavity, such as the vagina 4B or a hiatal cavityprepared prior to insertion of the tongue 114B. In a preferredembodiment, the tongue 114B has a central depression 136B and elevatededges 138B (FIG. 111 b), allowing compression of the tongue 114B sidesagainst the inferior surface of the pubic bone to counter the pressureof the compression foot 110B. Because of the shape of the tongue 114B,this type of pressure may be applied without crushing the urethra. Thetongue may also have a relatively broad elevated edge 138B contact pins140B for contacting the pubic bone. (FIGS. 123 and 124.) A flat tongue114B does not allow the application of a strong counterpressure againstthe bone, because of the potential damage to the urethra. (FIG. 111 a.)The tongue 114B has a first end 116B for inserting into the cavity, anda second end 118B which is adapted for articulating with the baseportion 108B of the upper clamp 102B. This articulation may be, forexample, by means of a threaded connector 107B that joins the tongue114B to the base portion 108B of the upper clamp 102B.

The lower clamp 120B of the driver frame assembly 100B has a buttockplate 122B for insertion beneath the patient such that the patient'sweight rests on the plate to further secure the frame assembly. Attachedto the buttock plate 122B is an ascending arm 124B that is adapted forarticulating with the base portion 108B of the upper clamp 102B. (FIG.112.) Thus, the upper clamp 102B attaches to the rigid catheter 52B andthe cavity tongue 114B, and then the upper clamp 102B also attaches tothe lower clamp 120B, which is anchored under the patient's body. Theeffect of these multiple attachments is to compress a patient's pelvicregion to provide stability for operation of the bone-piercing guidedriver 70B as well as to enhance the straight line precision of drivinga guide 84B through the pubic bone.

In a preferred embodiment, an insert card 30B capable of supporting amedical device is an additional component of the driver frame assembly100B. (FIG. 117.) In such an embodiment, the card 30B adapted to slidealong the tongue 114B to reach the proper position within the cavity.The articulation opening 40B of the card 30B also may be used forattachment or positional control of the card 30B with respect to thedriver frame assembly 100B.

The driver 70B portion of the driver frame assembly 100B is similar tothe driver 70B of a previous aspect of the invention as discussed above.The driver 70B of this aspect of the invention, however, does differ inthe respect that it attaches to the driver frame assembly 100B via theslide bar 80B of the driver 70B. Accordingly, the driver 70B of thisaspect of the invention has the slide bar 80B and the moveable jaw, butdoes not have its own immovable or first jaw 72B. However, uponattachment of the driver 70B to the driver frame assembly 100B, both thetongue 114B portion and the buttock plate 122B portion of the driverframe assembly 100B can simultaneously function as fixed jaws towardwhich the immovable jaw advances as it moves along the slide bar 80B.(FIG. 114.)

As mentioned above, the function of the first or fixed jaw is to providecounterpressure to the pressure applied to the pubic bone by theadvancement of the guide 84B through the pubic bone. The preferreddriver 70B portion of the driver frame assembly 100B has two positionsfor attachment of bone-piercing guides 84B to the second, or movable,jaw 72B. (FIG. 113.) These positions are left and right of center, beinglaterally spaced to provide sufficient offset from the patient's midlineso as to prevent any contact of the bone-piercing guides 84B with theurethra. Thus, the driver 70B of the assembly is intended tosimultaneously advance two separate bone-piercing guides 84B through thepubic bone, one left and one right of the patient's midline, as shown inFIG. 115.

This aspect of the invention provides a method for reconstruction of theurethral and pelvic floor or for stabilizing a tissue of the pelvicregion. In this method a rigid catheter 52B is placed in the urethra sothat the urethra is elongated and straightened. (FIG. 110.) The catheter52B also aids in determining the position of the bladder 46B and thebladder neck 47B. The tongue 114B of the driver frame assembly 100B isplaced into the tissue cavity, and also may be attached to the rigidcatheter 52B. (See FIGS. 110 and 111.) Preferably an insert card 30Bholding a medical device, for example, a urethral sling 42B, is insertedinto the cavity using the tongue 114B as a guide. (FIG. 117.) The upperclamp 102B is attached to the tongue 114B and to the catheter 52B, andthe compression foot 110B is compressed against the patient's abdomen,after palpation to determine the proper position of the stabilizing pins112B relative to the superior surface of the pubic bone. The compressionfoot 110B is tightened against the patient's abdomen to prevent slippingof the bone-piercing guide 84B, and to further immobilize the softtissues of the pelvis. (FIG. 110). Further stabilization is achievedwith attachment of the lower clamp 120B which is done by sliding thebuttock plate 122B beneath the patient and firmly attaching theascending arm 124B of the lower clamp 120B to the base portion 108B ofthe upper clamp 102B. (FIG. 112.)

With the driver frame assembly 100B properly installed along thepatient's midline, the driver 70B portion of the driver frame assembly100B may be mounted on the descending arm 106B of the upper clamp 102B.(FIG. 112.) Care is taken to assure that the bone-piercing guides 84B ofthe driver 70B are positioned such that they will enter the pubic bone.Then the second removable jaw of the driver 70B is advanced downwardalong the slide bar 80B and the guides 84B are advanced into theabdominal surface and through the pubic bone, emerging within the tissuecavity near the medical device supported on the card 30B. (FIG. 114.)

In a preferred example, the bone-piercing guides 84B are cannulas 90Band the medical device supported on the card 30B is a sling 42B. (FIGS.116 and 117.) In such an embodiment, the proximity of the cannulas 90Bwith the sling 42B permits suturing or other attachment through thelumen on the cannula 90B to the desired location on the urethral sling42B. (FIG. 118.) After attachment of suture 88B directly or indirectly(see FIGS. 120-122) to the sling 42B, the cannulas 90B are removed,leaving behind the suture 88B, which is then secured to the pubic bone.(FIG. 127.)

In another embodiment of this aspect of the invention, a concaveinsertion tongue 114B is used to provide counterpressure for drivingcannulas 90B through the pubic bone 45B. The concave tongue 114B isinserted into a cavity, such as, for example, a hiatal cavity or thevagina 4B, and the compression foot 110B of the driver frame assembly100B is placed against the patent's pubic bone 45B. (FIG. 123 a.) Theconcave tongue has a central depression 136B and elevated edges 138B,allowing the edges 138B of the tongue 114B to provide counterpressure tothe posterior/inferior surface of the pubic bone 45B, while thecompression foot 110B and the cannulas 90B apply pressure to theopposite (anterior/superior) surface of the bone 45B. (FIG. 123 b.)

The central depression 136B of the tongue 114B prevents the urethra 6Bfrom being crushed upon application of counter pressure on the bone 45Bby elevated edge 138B of the tongue 114B. (FIG. 123 b.) The edge of thetongue may also have a gap 144B to allow the cannula 90B to pass throughthe plane of the elevated edge 138B without the cannula 90B impactingagainst the tongue 114B. The edge 138B may also have contact pins 140Bof a configuration and position to pierce through soft tissue and fasciato contact the surface of the pubic bone 45B and prevent slippage of thetongue 114B. (FIG. 124.)

When pressure is applied to the opposite sides of the bone 45B, as shownin FIG. 123 b, the cannulas 90B are driven through the pubic bone 45Band into the cavity. (FIG. 125 a.) Suture 88B or other devices may bepassed through the cannulas 90B and into the cavity. (FIG. 125 b.) Thesuture 88B may be attached within the cavity either by stitches 92B orby attaching the suture 88B to a suture button 94B. (FIG. 125 b.) Afterproper attachment of the suture 88B within the cavity, the pressure onboth sides of the bone 45B is released, and the compression foot 110B israised. (FIG. 126 a.) The tongue 114B is removed from the cavity, andthe sutures attached therein are fastened to the bone 45B with, forexample, either a bone eyelet 150B or a bone suture fastener 170B. Theurethra 6B is elevated by the tension that is applied to the sutures 88Bin the step of fastening the sutures 88B to the bone 45B. The resultingelevation of the urethra 6B is shown as distance B in FIGS. 126 a and126 b.

The advantage of the method of this aspect of the invention is that thedriver frame assembly 100B, if properly installed, provides rigidity tothe driver 70B to allow for highly accurate straight line passage of abone-piercing guide 84B through the pubic bone and to a target sightwithin the soft tissue. Because the driver 70B is able to advance twodifferent guides 84B through the bone at the same time, and because thecontact between the guide 84B and the sling 42B is relatively precise,the entire procedure can be done very rapidly and with minimal invasioncompared with other procedures used to achieve a similar objective. Inaddition, the method of this aspect of the invention, being minimallyinvasive, greatly reduces the risk of infection arising from theprocedure. Also reduced is the number of incisions, resulting in ashorter recovery time for the patient and less scarring, since theexternal abdominal wounds are all puncture wounds, and the only incisionis a relatively small incision or a knife stick in the vaginal hiatus 2Bor in the upper vaginal wall 8B. In a preferred embodiment of thisaspect of the invention, the sutures 88B which pass through the bone aresecured to the bone after being tensioned with a suture tensioningdevice as discussed above.

Another aspect of the invention provides a system for attaching urethralsling 42B to a suture 88B as shown in FIG. 120-122. The system includesa urethral sling 42B and a connector 130B; the urethral sling 42B has aring member 44B attached thereto (FIGS. 128-129) and the connector 130Bis adapted to cooperate with the ring member 44B to permitunidirectional passage of the connector 130B through the ring member 44B(FIGS. 120-122, 131-134). The ring member 44B and the connector 130Bfurther cooperate to prevent retrograde movement of the connector 130Bthrough the ring member 44B.

The invention contemplates several embodiments both of the ring member44B and of the connector 130B. The ring member 44B may be as simple as ahole in an appropriate part of the sling 42B, suited for passagetherethrough by a connector 130B. (FIG. 132-134.) The ring member 44Balso may be a more elaborate structure, such as a reinforced ring withflanges 142B protruding into the central opening 128B of the ring member44B. (FIGS. 128, 129, 131.)

In a preferred embodiment, the connector 130B has a conical tip 131Battached to a cylindrical portion 133B behind the tip 131B to which asuture 88B may attach. This embodiment is referred to as the arrowheadconnector 132B. (FIG. 131.) The cylindrical portion 133B behind the tip131B has a smaller circumference than the widest part of the conical tip131B, such that there is a substantially flat shoulder 129B behind thetip 131B. Accordingly, the arrowhead connector 132B is adapted forcooperating with the reinforced ring member 44B having flanges 142B thatprotrude into the central opening 128B. As the tip 131B penetrates thecentral opening 128B, the flanges 142B move aside, allowing passage ofthe tip 131B. However, once the entire conical portion of the tip 131Bhas passed through the central opening 128B, the flanges 142B return totheir initial orientation around the central opening 128B and restagainst the shoulder 129B, resisting retrograde movement of theconnector 130B through the ring member 44B. (FIGS. 121, 122, 129, 131.)Since the cylindrical portion 133B behind the shoulder 129B of thearrowhead connector 132B has a means for connecting to a suture 88B, thepassage of the connector 130B through the ring member 44B creates aconnection between the suture 88B and the sling 42B. (FIG. 131.) By thismethod of connecting suture 88B to sling 42B, there is no need forstitching or tying knots to the sling 42B, which greatly simplifies andaccelerates the securing procedure.

Another preferred embodiment of the securing device 126B has a connector130B with two perpendicular cylindrical members 135B, 137B wherein themembers 135B, 137B are substantially flexibly attached one to the otherat a flexible joint 139B. (FIG. 133.) The rear cylinder 135B has a meansof attaching to a suture 88B, while the leading cylinder 137B is adaptedfor passage through the ring member 44B. As this embodiment of theconnector 130B, referred to herein as the T connector 134B, is insertedinto a cannula 90B for advancement toward the sling 42B, theperpendicularity between the two cylindrical members 135B, 137B isdistorted, and the leading cylinder 137B assumes a position that is moreclosely parallel, rather than perpendicular, to the rearward cylinder135B. (FIG. 134.) However, after the T connector 134B has passed throughthe cannula 90B and the leading cylinder 137B of the T connector 134Bhas also passed through the ring member 44B of the sling 42B, theangular relationship between the two cylindrical members 135B, 137Breverts to perpendicular. (FIG. 132.) In this conformation, theconnector 130B may not pass back through the ring member 44B, and asecure connection between the suture 88B and the sling 42B is thereforeestablished.

This aspect of the invention provides a method for simple, minimallyinvasive placement and securing of a sling 42B in a tissue cavity. Atissue cavity, such as a cavity in the hiatal tissue, is created by useof, for example, the dilator 10B or the incision guide 50B of theinvention. Alternatively an existing tissue cavity, such as the vagina4B, may be selected for placement of the sling 42B. In addition, atissue cavity in the hiatal tissue may be created by inserting a dilator10B or an incision guide 50B through the upper vaginal wall 8B. A sling42B is then placed into the cavity in its desired location. This step ispreferably performed with the use of the insert card 30B of theinvention, wherein the insert card 30B carries and supports the sling42B in its appropriate position within the cavity until it securedthere. (FIG. 117.)

A cannula 90B is driven through the pubic bone using, for example,either the driver 70B of the invention or the driver frame assembly 100Bof the invention. (FIG. 117.) The cannula 90B is then further driventhrough tissue until it approaches and aligns with the sling 42B, (FIG.118.) which is equipped with ring members 44B. A connector 130B attachedto the suture 88B is then inserted into the lumen of the cannula 90B andadvanced therethrough until it contacts with and passes through the ringmember 44B of the sling 42B. (FIGS. 119, 120, 121.) At this point, thesuture 88B is tested for the integrity of the connection between theconnector 130B and the ring member 44B, and the cannula 90B is withdrawnfrom the pubic bone. The suture 88B may then be appropriately tensionedand secured to the pubic bone (FIG. 127) as will be discussed below.Also contemplated as embodiments of this aspect of the invention aresimilar connections between other kinds of medical devices and suture88B via, for example, arrowhead connector 132B or T connector 134Bpassing through a cannula 90B which has been driven through the pubicbone.

As a further embodiment of the present invention, the securing devices126B of the invention may be used to secure a urethral sling 42B orother medical device after such a device has been positioned in a tissuecavity that was created transvaginally. For example, a cavity may beopened in the upper vaginal wall 8B by hydrodissection, or by means ofthe spreader 12B of the invention, or by blunt dissection. A medicaldevice such as a urethral sling 42B may then be placed into the cavity,wherein the medical device has one or more ring members 44B capable ofpermitting unidirectional passage of a connector 130B of the securingdevice 126B. The appropriate connector 130B is then passed through thecorresponding ring member 44B, and the device is secured in place in thetransvaginally created tissue pocket. (See FIG. 122.)

This invention is further characterized by a bone eyelet 150B forsecuring suture 88B to a bone. The bone eyelet 150B consists of a sleeve152B and at least one crosspiece 160B. (FIG. 130.) The sleeve 152B hasan outer surface 154B that is adapted for inserting into and contactingwith a bone, and also has an inner surface 156B such that the sleeve152B is a substantially hollow structure with openings at either end.(FIG. 131.) The crosspiece 160B is attached to the inner surface 156B ofthe sleeve 152B, and creates a plurality of channels within the sleeve152B.

Several alternative embodiments of the bone eyelet 150B are contemplatedin the present invention. In one preferred embodiment, the crosspiece160B is a single rod 164B. (FIG. 132.) In another preferred embodiment,the crosspiece 160B is a plane 162B. (FIG. 131.) In both of theseembodiments, the presence of the single crosspiece 160B produces twochannels 168B through which a suture 88B may pass. In anotherembodiment, the crosspiece 160B is created by crimping or piercing thesleeve 152B. In this embodiment, the thus-distorted portion of thesleeve 152B becomes the crosspiece 160B, as shown in FIG. 131. In otherembodiments, multiple crosspieces 160B may be present in the sleeve152B, to produce more than two channels 168B through which a suture 88Bmay pass. In another embodiment, the sleeve 152B includes aperpendicular flange rim 158B. This flange rim 158B suspends the sleeve152B at the surface of the bone and prevents it from sliding into thehole in the bone. (FIGS. 130-132.)

This aspect of the invention provides a method for securing a suture 88Bto a bone. In this method, a suture 88B is passed through a bone inwhich a path for suture 88B has been created, for example, by driving abone-piercing guide 84B according to this invention. Where two ends of asuture 88B both extend past the surface of the bone, each end may beadvanced through one of the channels 168B among the plurality ofchannels 168B provided in the bone eyelet 150B. The suture 88B ends maythen be tied together and will be prevented from sliding into the boneby the action of the crosspiece 160B of the bone eyelet 150B. (See FIGS.131, 132.)

Another embodiment of this method includes a step of tensioning thesuture 88B during the tying step to achieve a desired elevation of thestructures to which the suture 88B is attached. For example, this methodmay be employed in connection with a securing device 126B discussedabove to greatly accelerate and simplify the steps in securing a tissuemass or a urethral sling 42B in a tissue cavity. (FIGS. 131, 132.)Accordingly, the bone eyelet 150B may be used in connection with thedriver 70B aspect of the this invention, as well as the driver frameassembly 100B aspect of the invention. It may further be adapted for usewith other means of advancing a suture 88B through a pubic bone.

A further aspect of the present invention provides a bone suturefastener 170B for quick and simplified connection of a suture 88B to abone. (FIGS. 135-137.) The suture fastener 170B consists of a sleeve172B having an opening 174B at each end, and a sleeve plug 178B. Thesleeve 172B is provided with a friction surface 180B for contacting thesleeve plug 178B and for preventing disengagement of the plug 178B fromthe sleeve 172B. Different embodiments of the bone suture fastener 170Bhave a sleeve 172B that is substantially conical or cylindrical and asleeve plug 178B that is likewise substantially conical or cylindrical.In one embodiment the friction surface 180B is a plurality of frictionflanges 184B partially occluding one opening 174B of the suture fastenersleeve 172B. (FIGS. 135, 136 a.) These flanges 184B flex is onedirection to allow insertion of the sleeve plug 178B into the sleeve172B and then prevent release of the sleeve plug 178B from the sleeve172B. In another embodiment, the friction surface 180B is threaded 182Band the sleeve 172B is substantially cylindrical. (FIG. 137.) The sleeveplug 178B is likewise threaded 182B and is adapted for frictionallycontacting the threads 182B of the suture fastener sleeve 172B. Anadditional embodiment, the sleeve plug 178B may have a series ofdistortable angled rings 179B along its length, wherein thecircumference of the top of each ring 179B is smaller than thecircumference of the bottom of the same ring 179B. The suture 88B may betied directly to the sleeve plug 178B. In this embodiment, the frictionsurface 180B of the sleeve 172B has a rim 183B adapted to allowunidirectional passage of the sleeve plug 178B and to prevent retrogradepassage thereof, resulting in a one-way zipper-lock action. Thisembodiment allows a surgeon to adjust the tension on the suture 88Bsimply by pulling the sleeve plug 178B through the sleeve 172B to thedesired position. (FIG. 136 b.) In any of these embodiments, a flangerim 186B may extend around the circumference of one end of the sleeve172B to prevent sinking of the bone suture fastener 170B past thesurface of the bone. (FIG. 137.)

This aspect of the invention provides a method for quick and simplesecuring of a suture 88B that has passed through a bone. According tothe method, one or multiple ends of a suture 88B may be passed throughthe sleeve 172B of the suture fastener 170B and the suture fastener 170Bmay be advanced along the suture 88B until it contacts the bone throughwhich the suture 88B passes. (FIG. 135.) The sleeve 172B is secured inthe bone near the bone surface either by a friction surface 180B on theoutside of the sleeve 172B, or by a flange rim 186B extending around thecircumference of one end of the sleeve 172B. With the sleeve 172B inplace, and the suture 88B passing therethrough, the suture 88B may betensioned to approximately the desired tension and the sleeve plug 178Bpartially inserted into the opening 174B of the sleeve 172B at thesurface of the bone. Any desired tensioning or release of tension in thesuture 88B is done prior to final seating of the sleeve plug 178B in thesleeve 172B against the friction surface 180B. (FIGS. 136 a and 137.)When the sleeve plug 178B is appropriately seated against the frictionsurface 180B, the suture 88B is secured in place at the surface of thebone, and excess suture 88B is cut off by the surgeon.

Another embodiment of this aspect of the invention contemplates the useof the bone suture fastener 170B to secure a suture 88B that isconnected to a device or a stitch 92B in a transvaginally created tissuecavity. For example, a tissue cavity is dissected between the urethraand the upper vaginal wall 8B by hydrodissection, blunt instrumentdissection, or by the spreader 12B of the invention. Subsequently, asling 42B or other medical device may be placed in the cavity, or asuture 88B may be passed through a tissue mass to elevate or stabilizethe tissue mass (compare FIG. 126 a to FIG. 126 b and note distance ofelevation B, see also FIGS. 108, 109, 125).

In cases where the suture 88B is passed through the tissue and follows apath through the pubic bone, the end of the suture 88B that protrudesfrom the pubic bone may be anchored thereto by means of the bone suturefastener 170B of this aspect of the invention. (FIG. 127.)

This method of the invention may be practiced in cooperation withseveral other methods and devices of the present invention. In anyaspect of the invention in which a suture 88B is passed through a bone,the suture 88B may be advantageously secured to the bone in this manner.Thus, the quick connect bone suture fastening may be used incoordination with the quick connect securing devices 126B used toconnect a sling 42B or other internally placed medical device with asuture 88B. They also may be used to secure the ends of a suture 88Bthat has been passed through a tissue mass by stitching 92B. They alsomay be used in connection with the bone-piercing guide driver 70B orwith the driver frame assembly 100B of the invention.

Accordingly, the several aspects of the present invention cooperate toachieve the desired effect of providing a variety of surgical optionsfor and solutions to problems associated with stress urinaryincontinence and related dysfunctions or deformations of the urethral orpelvic floor. Also contemplated within the overall scope of the presentinvention are other applications for securing a soft target tissue to arelatively fixed reference tissue, such as the pubic bone. It isunderstood that the examples of embodiments and methods provided hereinare merely representative of the invention, and are not taken to limitthe invention beyond the express limitations of the following claims.

1. A guide member placement device for inserting a guide member in abody tissue, comprising: a handle; a shaft attached to said handle andhaving a proximal end, a distal end, and a lumen extending therethrough,said lumen adapted for receiving a guide member; and an engaging memberat said distal end of said shaft adapted to engage another guide memberplacement device.
 2. The guide member placement device of claim 1,wherein the engaging member comprises a male connector configured to bereleasably couple to a female connector on the second guide memberdevice.
 3. The guide member placement device of claim 1, wherein theshaft includes a straight proximal section, a bent intermediate sectionand a distal section, the distal section being oriented at an angle ofapproximately 90 degrees relative to the proximal section.
 4. The guidemember placement device of claim 1, further comprising a guide memberremovably positioned in the lumen of the shaft.
 5. The guide memberplacement device of claim 4, wherein the guide member comprises aguidewire.
 6. The guide member placement device of claim 4, wherein theguide member comprises a suture.
 7. The guide member placement device ofclaim 1, further comprising an axially-movable blunt dissection tippositioned near the distal end of the shaft.
 8. The guide memberplacement device of claim 7, wherein the blunt dissection tip ispositioned on a blunt dissector disposed within the lumen of the shaft,the blunt dissection tip being extendable from and retractable into theshaft.
 9. The guide member placement device of claim 8, wherein theblunt dissector is biased toward a retracted position.
 10. The guidemember placement device of claim 8, wherein the blunt dissectorcomprises a narrow portion including a lumen, the narrow portion beingconnected to a body portion located within the handle.
 11. The guidemember placement device of claim 8, wherein a body portion of the bluntdissector comprises a recessed portion and a spring, the recess portionbeing adapted for receiving the spring which biases the blunt dissectortoward the retracted position.
 12. The guide member placement device ofclaim 8, further comprising a rotatable cam adapted to place an axialdistal force upon a body portion of the blunt dissector to thereby placeblunt dissector tip in the extended position.
 13. The guide memberplacement device of claim 10, wherein a body portion of the bluntdissector comprises a lumen which is in fluid communication with a lumendisposed in the narrow portion of the blunt dissector.
 14. The guidemember placement device of claim 8, wherein a body portion of the bluntdissector has an axial range of motion from about 2 mm to about 10 mm.15. The guide member placement device of claim 1, wherein the shaft andthe handle are oriented along a common longitudinal axis.
 16. The guidemember placement device of claim 1, wherein at least part of theexterior surface of the handle is textured to produce a high-frictiongripping surface.
 17. The guide member placement device of claim 1,wherein the distal end of the shaft is oriented at an angle ofapproximately 90 degrees relative to the handle.